Affected Product: Polyethylene Implants from Gender Solutions Natural-Knee Flex, Natural-Knee, Natural-Knee II, MOST Options, and Apollo Systems



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Transcription:

March 19, 2014 To: Surgeons Subject: URGENT MEDICAL DEVICE RECALL NOTIFICATION Zimmer reference: 1822565-02-07-2014-001-R Affected Product: Polyethylene Implants from Gender Solutions Natural-Knee Flex, Natural-Knee, Natural-Knee II, MOST Options, and Apollo Systems Zimmer is initiating a voluntary recall of a small subset of the Affected Product due to a single complaint of discoloration. You are receiving this letter because our records indicate that you may have received or implanted the Affected Product. The Affected Product was distributed between October 31, 2006 and January 31, 2014. Zimmer received a single complaint regarding discoloration of a Natural-Knee II All Poly Congruent Tibia. An investigation into the event found that the discoloration was caused by oxidation resulting from prolonged exposure to artificial light after being machined by a third party supplier and awaiting completion and sterile packaging at Zimmer s manufacturing facility. The majority of Zimmer polyethylene implants are machined or molded by Zimmer and promptly sterile packaged and completed, meaning that this phenomenon was only observed in less than 2% of the Affected Product. As part of its investigation, Zimmer determined through testing that polyethylene implants exposed to artificial light for greater than one (1) year had increased oxidation index levels (though still well below the levels scientifically recognized to have clinical impact) and decreased tensile strength. As a result, Zimmer is voluntarily recalling all lots of articulating polyethylene implants that were potentially exposed to artificial light prior to sterilization and completion for greater than one year. It is important to note that there have been no patient injuries reported related to the Affected Product as a result of discoloration or elevated oxidation. The storage process has been updated to prevent this type of occurrence in the future. The affected manufacturing lots produced prior to this change are listed in Attachment 1. Risks If discoloration is detected intra-operatively there may be a surgical delay to obtain and prepare for an alternative implant, however no injuries or illness would be expected. A polyethylene implant with an elevated oxidation level could result in premature implant failure in comparison to a polyethylene implant without elevated oxidation levels. This is due to the potential for an increased amount of polyethylene wear and delamination, which can lead to osteolysis and implant loosening. Implant loosening would likely result in revision surgery. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the list in Attachment 1, quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please contact your Zimmer contact person. Page 1 of 16

Vigilance Information This voluntary notification will be reported to the U.S. Food and Drug Administration and to the local Competent Authorities. Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported according to MEDDEV 2.12-1 Rev. 8 to the local health authority in your country. Please keep Zimmer informed of any adverse events associated with this device or any other Zimmer product. Adverse events may be reported to Zimmer at zimmer.per@zimmer.com, or to your local Zimmer representative. Kind regards Field Action Manager Corporate Quality & Compliance Page 2 of 16

ATTACHMENT 1 Item Lot General Description 502001016 60612572 MOST Options System (MOST) Tibia Insert 502001016 60687272 MOST Options System (MOST) Tibia Insert 502001016 60707884 MOST Options System (MOST) Tibia Insert 502001016 60812397 MOST Options System (MOST) Tibia Insert 502001016 60846427 MOST Options System (MOST) Tibia Insert 502001016 61047430 MOST Options System (MOST) Tibia Insert 502004006 60984403 MOST Options System (MOST) Tibia Insert 502004009 61188395 MOST Options System (MOST) Tibia Insert 502004016 61011775 MOST Options System (MOST) Tibia Insert 502010006 61930083 MOST Options System (MOST) Proximal Tibia Insert 00541800000 61460914 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61482392 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61485677 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61502813 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61507021 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61510762 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61516637 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61516638 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61516639 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61518651 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61518652 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61525153 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61528254 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61528255 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61528256 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61528257 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61530238 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61530239 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61570708 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61570709 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61570711 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61570712 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61570715 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61577049 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61577051 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61577053 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581732 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581733 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581734 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581737 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581738 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61581742 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61592968 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 3 of 16

00541800000 61592969 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61592971 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61592972 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61592974 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61604857 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61604859 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61629217 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61629223 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61629227 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61635504 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61635505 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61651160 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61651161 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61661455 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800000 61677136 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61454418 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61460915 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61470878 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61470879 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61470880 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61470881 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61510763 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61512394 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61516640 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61525154 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61528258 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61528259 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61528260 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61570710 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61570713 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61570716 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61577050 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61577052 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61581735 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61581739 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61581740 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61581743 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61592970 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61592973 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61592975 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61598744 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61604860 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61629214 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61629215 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61629219 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 4 of 16

00541800001 61629220 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61629226 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61629228 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61635506 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61635507 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61651162 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61656382 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61661454 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61670292 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61677129 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800001 61689741 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 11004737 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61722944 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61754199 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61782960 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61782961 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61782962 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61788494 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61788495 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61808566 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61816228 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61827844 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61834994 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61847240 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61865451 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61875629 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61894180 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61900219 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61913146 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61920378 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61936311 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61951473 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61951475 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61973952 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 61990690 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62003139 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62011271 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62017364 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62019623 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62031742 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62031743 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62059897 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62080439 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62088676 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00541800002 62088685 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 5 of 16

00541800002 62112252 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component 00591101128 61729684 Natural-Knee II System All Poly Patella 00591101128 61840888 Natural-Knee II System All Poly Patella 00591101137 61661494 Natural-Knee II System All Poly Patella 611001009 60619111 Natural-Knee II System Unicompartmental Tibia Inserter 611001009 60713065 Natural-Knee II System Unicompartmental Tibia Inserter 611001009 60786858 Natural-Knee II System Unicompartmental Tibia Inserter 611001009 60812384 Natural-Knee II System Unicompartmental Tibia Inserter 611001009 60928258 Natural-Knee II System Unicompartmental Tibia Inserter 611001011 61129248 Natural-Knee II System Unicompartmental Tibia Inserter 611001011 61140472 Natural-Knee II System Unicompartmental Tibia Inserter 611001011 61140475 Natural-Knee II System Unicompartmental Tibia Inserter 611001011 61162218 Natural-Knee II System Unicompartmental Tibia Inserter 611001013 61135505 Natural-Knee II System Unicompartmental Tibia Inserter 611001013 61140487 Natural-Knee II System Unicompartmental Tibia Inserter 611002009 61808358 Natural-Knee II System Unicompartmental Tibia Inserter 611002009 61842970 Natural-Knee II System Unicompartmental Tibia Inserter 611002009 61913067 Natural-Knee II System Unicompartmental Tibia Inserter 611002009 62049519 Natural-Knee II System Unicompartmental Tibia Inserter 611002009 62153667 Natural-Knee II System Unicompartmental Tibia Inserter 611002011 60928262 Natural-Knee II System Unicompartmental Tibia Inserter 611002011 60928263 Natural-Knee II System Unicompartmental Tibia Inserter 611002011 60928264 Natural-Knee II System Unicompartmental Tibia Inserter 611002011 60928265 Natural-Knee II System Unicompartmental Tibia Inserter 611002011 61129245 Natural-Knee II System Unicompartmental Tibia Inserter 611002013 61110613 Natural-Knee II System Unicompartmental Tibia Inserter 611002013 61129246 Natural-Knee II System Unicompartmental Tibia Inserter 611002013 61129247 Natural-Knee II System Unicompartmental Tibia Inserter 611002013 61207467 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60713069 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60781677 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60836175 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60842071 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60867881 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60884719 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60902204 Natural-Knee II System Unicompartmental Tibia Inserter 611003009 60902206 Natural-Knee II System Unicompartmental Tibia Inserter 611003011 61110614 Natural-Knee II System Unicompartmental Tibia Inserter 611003011 61129243 Natural-Knee II System Unicompartmental Tibia Inserter 611003011 61129244 Natural-Knee II System Unicompartmental Tibia Inserter 611003011 61190236 Natural-Knee II System Unicompartmental Tibia Inserter 611003013 61135503 Natural-Knee II System Unicompartmental Tibia Inserter 611003013 61135504 Natural-Knee II System Unicompartmental Tibia Inserter 611003013 61140464 Natural-Knee II System Unicompartmental Tibia Inserter 611003013 61150595 Natural-Knee II System Unicompartmental Tibia Inserter Page 6 of 16

613001007 61385990 Natural-Knee II System Unicompartmental Tibia Inserter 613001009 61269858 Natural-Knee II System Unicompartmental Tibia Inserter 620001100 60674275 Natural-Knee II System Metal Backed Patella Component 620001100 61566657 Natural-Knee II System Metal Backed Patella Component 620001100 61587666 Natural-Knee II System Metal Backed Patella Component 620001100 61650258 Natural-Knee II System Metal Backed Patella Component 620001100 61681080 Natural-Knee II System Metal Backed Patella Component 620001100 62151759 Natural-Knee II System Metal Backed Patella Component 620001100 62261472 Natural-Knee II System Metal Backed Patella Component 620001100 62274638 Natural-Knee II System Metal Backed Patella Component 620001100 62274645 Natural-Knee II System Metal Backed Patella Component 620001100 62283811 Natural-Knee II System Metal Backed Patella Component 620001100 62298755 Natural-Knee II System Metal Backed Patella Component 620001100 62322959 Natural-Knee II System Metal Backed Patella Component 620001101 61487827 Natural-Knee II System Metal Backed Patella Component 620001101 61587665 Natural-Knee II System Metal Backed Patella Component 620001101 61621642 Natural-Knee II System Metal Backed Patella Component 620001101 61650259 Natural-Knee II System Metal Backed Patella Component 620001101 61676693 Natural-Knee II System Metal Backed Patella Component 620001101 61702703 Natural-Knee II System Metal Backed Patella Component 620001101 61740149 Natural-Knee II System Metal Backed Patella Component 620001101 61781730 Natural-Knee II System Metal Backed Patella Component 620001102 60531353 Natural-Knee II System Metal Backed Patella Component 620001102 61505267 Natural-Knee II System Metal Backed Patella Component 620001102 61615680 Natural-Knee II System Metal Backed Patella Component 620001102 61707733 Natural-Knee II System Metal Backed Patella Component 620001102 61754019 Natural-Knee II System Metal Backed Patella Component 620001102 61865180 Natural-Knee II System Metal Backed Patella Component 620001102 61940711 Natural-Knee II System Metal Backed Patella Component 620001102 61995984 Natural-Knee II System Metal Backed Patella Component 620001102 62195133 Natural-Knee II System Metal Backed Patella Component 620001102 62225725 Natural-Knee II System Metal Backed Patella Component 620001102 62322961 Natural-Knee II System Metal Backed Patella Component 620005819 61091304 Natural-Knee Congruent Tibial Insert with Screw 620005909 62049531 Natural-Knee Congruent Tibial Insert with Screw 620006916 61066561 Natural-Knee Congruent Tibial Insert with Screw 621800809 61016365 Natural-Knee II System All Poly Ultra Congruent Tibia 621801809 61722681 Natural-Knee II System All Poly Ultra Congruent Tibia 621801809 62188790 Natural-Knee II System All Poly Ultra Congruent Tibia 621801819 60923828 Natural-Knee II System All Poly Ultra Congruent Tibia 621801819 61129203 Natural-Knee II System All Poly Ultra Congruent Tibia 621801913 61330819 Natural-Knee II System All Poly Ultra Congruent Tibia 621801913 61834837 Natural-Knee II System All Poly Ultra Congruent Tibia 621801916 61009484 Natural-Knee II System All Poly Ultra Congruent Tibia 621801916 61487209 Natural-Knee II System All Poly Ultra Congruent Tibia Page 7 of 16

621810816 61717377 Natural-Knee II System All Poly Ultra Congruent Tibia 621810816 62112290 Natural-Knee II System All Poly Ultra Congruent Tibia 621810909 61348036 Natural-Knee II System All Poly Ultra Congruent Tibia 621810909 62060282 Natural-Knee II System All Poly Ultra Congruent Tibia 621820809 61990695 Natural-Knee II System All Poly Ultra Congruent Tibia 621820811 60923830 Natural-Knee II System All Poly Ultra Congruent Tibia 621820811 62207659 Natural-Knee II System All Poly Ultra Congruent Tibia 621820911 60757906 Natural-Knee II System All Poly Ultra Congruent Tibia 621820911 61074407 Natural-Knee II System All Poly Ultra Congruent Tibia 621820911 62088695 Natural-Knee II System All Poly Ultra Congruent Tibia 621830811 60765958 Natural-Knee II System All Poly Ultra Congruent Tibia 621830811 61323227 Natural-Knee II System All Poly Ultra Congruent Tibia 621830811 62105429 Natural-Knee II System All Poly Ultra Congruent Tibia 621830909 61240169 Natural-Knee II System All Poly Ultra Congruent Tibia 621850916 62188788 Natural-Knee II System All Poly Ultra Congruent Tibia 625001609 61074797 Natural-Knee II Ultra Congruent Tibial Insert 625001609 61085748 Natural-Knee II Ultra Congruent Tibial Insert 625001609 61188694 Natural-Knee II Ultra Congruent Tibial Insert 625001613 60548568 Natural-Knee II Ultra Congruent Tibial Insert 625001613 61121435 Natural-Knee II Ultra Congruent Tibial Insert 625001613 61419333 Natural-Knee II Ultra Congruent Tibial Insert 625001613 61567373 Natural-Knee II Ultra Congruent Tibial Insert 625001613 62195341 Natural-Knee II Ultra Congruent Tibial Insert 625001619 61085742 Natural-Knee II Ultra Congruent Tibial Insert 625001619 61567371 Natural-Knee II Ultra Congruent Tibial Insert 625001709 60886831 Natural-Knee II Ultra Congruent Tibial Insert 625001709 60976516 Natural-Knee II Ultra Congruent Tibial Insert 625001709 61091795 Natural-Knee II Ultra Congruent Tibial Insert 625001711 62127482 Natural-Knee II Ultra Congruent Tibial Insert 625001713 60872580 Natural-Knee II Ultra Congruent Tibial Insert 625001713 60979731 Natural-Knee II Ultra Congruent Tibial Insert 625001713 61699518 Natural-Knee II Ultra Congruent Tibial Insert 625001719 61219748 Natural-Knee II Ultra Congruent Tibial Insert 625002613 61827810 Natural-Knee II Ultra Congruent Tibial Insert 625002616 61085656 Natural-Knee II Ultra Congruent Tibial Insert 625002616 61162828 Natural-Knee II Ultra Congruent Tibial Insert 625002616 61253229 Natural-Knee II Ultra Congruent Tibial Insert 625002719 61232452 Natural-Knee II Ultra Congruent Tibial Insert 625002719 61312433 Natural-Knee II Ultra Congruent Tibial Insert 625002722 61102130 Natural-Knee II Ultra Congruent Tibial Insert 630809510 61003976 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630809510 61107491 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630811410 60956303 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630811410 61847308 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630811510 60902038 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Page 8 of 16

630811510 61847307 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630813410 60902039 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630813410 61782747 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630813410 61847309 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630813510 60902036 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630813510 61811364 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816210 60946833 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816210 61811365 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816210 62188786 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816410 61085003 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816410 61808182 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816410 61834828 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816510 60875580 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816510 61814416 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630816510 61857141 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819010 61875213 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819010 62157103 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819110 61814417 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819110 61824703 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819210 60902037 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819310 61599381 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819310 61814418 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819410 61814419 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819410 61825403 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 630819510 60902040 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert 635000009 62026046 Natural-Knee II System All Poly Congruent Tibia 635001009 60996796 Natural-Knee II System All Poly Congruent Tibia 635001009 61184673 Natural-Knee II System All Poly Congruent Tibia 635001011 61052406 Natural-Knee II System All Poly Congruent Tibia 635001011 61782748 Natural-Knee II System All Poly Congruent Tibia 635001111 61129156 Natural-Knee II System All Poly Congruent Tibia 635001111 61566726 Natural-Knee II System All Poly Congruent Tibia 635001116 61175171 Natural-Knee II System All Poly Congruent Tibia 635002009 60757894 Natural-Knee II System All Poly Congruent Tibia 635002009 61016364 Natural-Knee II System All Poly Congruent Tibia 635002009 61520050 Natural-Knee II System All Poly Congruent Tibia 635002011 61160880 Natural-Knee II System All Poly Congruent Tibia 635002011 61516858 Natural-Knee II System All Poly Congruent Tibia 635002011 61686052 Natural-Knee II System All Poly Congruent Tibia 635002011 61940750 Natural-Knee II System All Poly Congruent Tibia 635002109 60940084 Natural-Knee II System All Poly Congruent Tibia 635002111 60591562 Natural-Knee II System All Poly Congruent Tibia 635002111 60902055 Natural-Knee II System All Poly Congruent Tibia 635002111 61175172 Natural-Knee II System All Poly Congruent Tibia 635002111 62112285 Natural-Knee II System All Poly Congruent Tibia Page 9 of 16

635002113 61107559 Natural-Knee II System All Poly Congruent Tibia 635002113 61520049 Natural-Knee II System All Poly Congruent Tibia 635003009 60902053 Natural-Knee II System All Poly Congruent Tibia 635003009 60902054 Natural-Knee II System All Poly Congruent Tibia 635003009 61160882 Natural-Knee II System All Poly Congruent Tibia 635003011 60902051 Natural-Knee II System All Poly Congruent Tibia 635003011 61062788 Natural-Knee II System All Poly Congruent Tibia 635003011 61184646 Natural-Knee II System All Poly Congruent Tibia 635003013 61058081 Natural-Knee II System All Poly Congruent Tibia 635003013 61184676 Natural-Knee II System All Poly Congruent Tibia 635003013 61782750 Natural-Knee II System All Poly Congruent Tibia 635003016 61129149 Natural-Knee II System All Poly Congruent Tibia 635003016 61242110 Natural-Knee II System All Poly Congruent Tibia 635003109 60902052 Natural-Knee II System All Poly Congruent Tibia 635003109 60908325 Natural-Knee II System All Poly Congruent Tibia 635003109 61184657 Natural-Knee II System All Poly Congruent Tibia 635003109 61717374 Natural-Knee II System All Poly Congruent Tibia 635003109 61950477 Natural-Knee II System All Poly Congruent Tibia 635003113 61878438 Natural-Knee II System All Poly Congruent Tibia 635003116 61129158 Natural-Knee II System All Poly Congruent Tibia 635003116 61184675 Natural-Knee II System All Poly Congruent Tibia 635004009 61899915 Natural-Knee II System All Poly Congruent Tibia 635004009 62191926 Natural-Knee II System All Poly Congruent Tibia 635004009 61175095 Natural-Knee II System All Poly Congruent Tibia 635004009 60781217 Natural-Knee II System All Poly Congruent Tibia 635004011 61717375 Natural-Knee II System All Poly Congruent Tibia 635004016 61111635 Natural-Knee II System All Poly Congruent Tibia 635004016 61184649 Natural-Knee II System All Poly Congruent Tibia 635004111 61160890 Natural-Knee II System All Poly Congruent Tibia 635004111 61973957 Natural-Knee II System All Poly Congruent Tibia 635004113 61184651 Natural-Knee II System All Poly Congruent Tibia 635004113 61949828 Natural-Knee II System All Poly Congruent Tibia 635004119 61147593 Natural-Knee II System All Poly Congruent Tibia 635005013 61184652 Natural-Knee II System All Poly Congruent Tibia 635005013 61950474 Natural-Knee II System All Poly Congruent Tibia 635005019 61119496 Natural-Knee II System All Poly Congruent Tibia 635005019 61135549 Natural-Knee II System All Poly Congruent Tibia 635005111 61085021 Natural-Knee II System All Poly Congruent Tibia 635005111 61150539 Natural-Knee II System All Poly Congruent Tibia 635005111 61592577 Natural-Knee II System All Poly Congruent Tibia 635005116 61129162 Natural-Knee II System All Poly Congruent Tibia 635005116 61184677 Natural-Knee II System All Poly Congruent Tibia 635006109 61129153 Natural-Knee II System All Poly Congruent Tibia 635006109 61184659 Natural-Knee II System All Poly Congruent Tibia 670501916 62097955 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Page 10 of 16

670501916 62188801 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 60490437 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 60908398 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61013451 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61091888 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61118370 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61213573 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61223653 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670501919 61251657 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60631734 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60728035 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60737467 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60737468 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60826364 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60846402 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 60902182 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61007106 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61074465 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61074466 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61091881 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61286937 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61865302 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 61868154 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 62157118 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 62297652 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670502811 62298396 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503819 61052443 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503819 61169351 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503911 61650986 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61004133 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61004134 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61013460 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61058092 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61147605 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 670503916 61814420 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert 672009100 60598386 Natural-Knee II Constrained Knee System Tibia Insert 672009100 60742310 Natural-Knee II Constrained Knee System Tibia Insert 672009100 61990701 Natural-Knee II Constrained Knee System Tibia Insert 672009101 60681716 Natural-Knee II Constrained Knee System Tibia Insert 672009103 61434138 Natural-Knee II Constrained Knee System Tibia Insert 672009103 61782765 Natural-Knee II Constrained Knee System Tibia Insert 672009103 62017005 Natural-Knee II Constrained Knee System Tibia Insert 672009103 62162057 Natural-Knee II Constrained Knee System Tibia Insert 672009200 60856124 Natural-Knee II Constrained Knee System Tibia Insert 672009200 61639391 Natural-Knee II Constrained Knee System Tibia Insert Page 11 of 16

672009200 62055481 Natural-Knee II Constrained Knee System Tibia Insert 672009203 60923898 Natural-Knee II Constrained Knee System Tibia Insert 672009203 61016489 Natural-Knee II Constrained Knee System Tibia Insert 672009203 61367019 Natural-Knee II Constrained Knee System Tibia Insert 672009203 62088735 Natural-Knee II Constrained Knee System Tibia Insert 672011101 61016472 Natural-Knee II Constrained Knee System Tibia Insert 672011103 60693032 Natural-Knee II Constrained Knee System Tibia Insert 672011103 60946870 Natural-Knee II Constrained Knee System Tibia Insert 672011103 61147607 Natural-Knee II Constrained Knee System Tibia Insert 672011200 61475713 Natural-Knee II Constrained Knee System Tibia Insert 672011200 61827804 Natural-Knee II Constrained Knee System Tibia Insert 672011200 62049509 Natural-Knee II Constrained Knee System Tibia Insert 672011201 60624824 Natural-Knee II Constrained Knee System Tibia Insert 672011201 60737477 Natural-Knee II Constrained Knee System Tibia Insert 672011203 61016493 Natural-Knee II Constrained Knee System Tibia Insert 672011203 61571527 Natural-Knee II Constrained Knee System Tibia Insert 672011203 61923057 Natural-Knee II Constrained Knee System Tibia Insert 672011203 62127481 Natural-Knee II Constrained Knee System Tibia Insert 672013100 61016491 Natural-Knee II Constrained Knee System Tibia Insert 672013100 61650989 Natural-Knee II Constrained Knee System Tibia Insert 672013100 61729751 Natural-Knee II Constrained Knee System Tibia Insert 672013100 61788440 Natural-Knee II Constrained Knee System Tibia Insert 672013101 61118389 Natural-Knee II Constrained Knee System Tibia Insert 672013103 60693033 Natural-Knee II Constrained Knee System Tibia Insert 672013103 60908439 Natural-Knee II Constrained Knee System Tibia Insert 672013200 60786856 Natural-Knee II Constrained Knee System Tibia Insert 672013200 61016492 Natural-Knee II Constrained Knee System Tibia Insert 672013200 62097958 Natural-Knee II Constrained Knee System Tibia Insert 672013203 62148866 Natural-Knee II Constrained Knee System Tibia Insert 672016101 61788436 Natural-Knee II Constrained Knee System Tibia Insert 672016103 60990345 Natural-Knee II Constrained Knee System Tibia Insert 672016103 61426861 Natural-Knee II Constrained Knee System Tibia Insert 672016103 61487222 Natural-Knee II Constrained Knee System Tibia Insert 672016200 60737475 Natural-Knee II Constrained Knee System Tibia Insert 672016200 61286952 Natural-Knee II Constrained Knee System Tibia Insert 672016200 61717387 Natural-Knee II Constrained Knee System Tibia Insert 672016200 62088737 Natural-Knee II Constrained Knee System Tibia Insert 672016203 60707870 Natural-Knee II Constrained Knee System Tibia Insert 672016203 60946858 Natural-Knee II Constrained Knee System Tibia Insert 672016203 61788437 Natural-Knee II Constrained Knee System Tibia Insert 672019100 60693028 Natural-Knee II Constrained Knee System Tibia Insert 672019100 60990351 Natural-Knee II Constrained Knee System Tibia Insert 672019100 61592609 Natural-Knee II Constrained Knee System Tibia Insert 672019101 60710377 Natural-Knee II Constrained Knee System Tibia Insert 672019101 60923987 Natural-Knee II Constrained Knee System Tibia Insert Page 12 of 16

672019101 61650991 Natural-Knee II Constrained Knee System Tibia Insert 672019101 61788439 Natural-Knee II Constrained Knee System Tibia Insert 672019200 60804168 Natural-Knee II Constrained Knee System Tibia Insert 672019200 61323247 Natural-Knee II Constrained Knee System Tibia Insert 672019200 61827805 Natural-Knee II Constrained Knee System Tibia Insert 672019200 62088736 Natural-Knee II Constrained Knee System Tibia Insert 672019201 60624822 Natural-Knee II Constrained Knee System Tibia Insert 672019201 60792148 Natural-Knee II Constrained Knee System Tibia Insert 672019201 61617346 Natural-Knee II Constrained Knee System Tibia Insert 672019201 61956605 Natural-Knee II Constrained Knee System Tibia Insert 672019201 62127480 Natural-Knee II Constrained Knee System Tibia Insert 672022101 60923892 Natural-Knee II Constrained Knee System Tibia Insert 672022101 61434133 Natural-Knee II Constrained Knee System Tibia Insert 672022101 61883555 Natural-Knee II Constrained Knee System Tibia Insert 672022103 60696647 Natural-Knee II Constrained Knee System Tibia Insert 672022103 60990350 Natural-Knee II Constrained Knee System Tibia Insert 672022103 61305375 Natural-Knee II Constrained Knee System Tibia Insert 672022103 61923053 Natural-Knee II Constrained Knee System Tibia Insert 672022200 60792151 Natural-Knee II Constrained Knee System Tibia Insert 672022201 60624818 Natural-Knee II Constrained Knee System Tibia Insert 672022201 60737474 Natural-Knee II Constrained Knee System Tibia Insert 672022201 61012531 Natural-Knee II Constrained Knee System Tibia Insert 672022201 61782763 Natural-Knee II Constrained Knee System Tibia Insert 672022201 61974009 Natural-Knee II Constrained Knee System Tibia Insert 672025100 60693029 Natural-Knee II Constrained Knee System Tibia Insert 672025100 61923055 Natural-Knee II Constrained Knee System Tibia Insert 672025200 60792141 Natural-Knee II Constrained Knee System Tibia Insert 672025200 61363285 Natural-Knee II Constrained Knee System Tibia Insert 672025200 61974007 Natural-Knee II Constrained Knee System Tibia Insert 672509100 60909403 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509100 61074719 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509101 60713056 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509101 62017009 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509200 60909404 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509203 60863521 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509203 60909417 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672509203 61016552 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672511100 61274799 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672511103 60863519 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672511103 61007978 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672511103 61782768 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672513101 61363318 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672513101 61747147 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672513103 61016554 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672513103 61808357 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Page 13 of 16

672513201 60792157 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672513201 61754163 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672516103 60909395 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672516103 61016540 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672516103 61650994 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672519103 60909402 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672519103 61286990 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672522201 60909396 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672522201 61080279 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672525103 60747318 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 672525203 60792159 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert 680001000 61756167 Apollo Knee System Patella Component 681100019 61176049 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681100022 61282848 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681101009 61929803 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681101011 61929804 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681101019 61160228 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681102013 61990704 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681102019 61160229 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681103009 61990703 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681103013 61990702 Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert 681600016 61145695 Apollo Knee System Posterior Stabilized Tibial Insert 681600019 61207113 Apollo Knee System Posterior Stabilized Tibial Insert 681600022 61291144 Apollo Knee System Posterior Stabilized Tibial Insert 681601016 61183328 Apollo Knee System Posterior Stabilized Tibial Insert 681602016 61277999 Apollo Knee System Posterior Stabilized Tibial Insert 681602022 61287024 Apollo Knee System Posterior Stabilized Tibial Insert 681603016 61287025 Apollo Knee System Posterior Stabilized Tibial Insert 681603019 61175475 Apollo Knee System Posterior Stabilized Tibial Insert 681604009 61990705 Apollo Knee System Posterior Stabilized Tibial Insert 681604011 61179664 Apollo Knee System Posterior Stabilized Tibial Insert 681604013 61207114 Apollo Knee System Posterior Stabilized Tibial Insert 681604016 61920302 Apollo Knee System Posterior Stabilized Tibial Insert 681604019 61913087 Apollo Knee System Posterior Stabilized Tibial Insert 681604022 61291164 Apollo Knee System Posterior Stabilized Tibial Insert 681605009 61188482 Apollo Knee System Posterior Stabilized Tibial Insert 681605019 61150215 Apollo Knee System Posterior Stabilized Tibial Insert 682000016 61278008 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682001011 62157194 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682001016 60659970 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682001016 61929807 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682001022 61278014 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682001030 61175476 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682002011 62157193 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682002013 62083333 Apollo Revision/Constrained Knee System Constrained Tibial Insert Page 14 of 16

682002016 61972595 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682002022 61972596 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682002030 61929808 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682003016 62186237 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682003022 60659966 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682003025 60659968 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682003025 61930084 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682004013 61287029 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682004016 61326987 Apollo Revision/Constrained Knee System Constrained Tibial Insert 682005011 61287027 Apollo Revision/Constrained Knee System Constrained Tibial Insert Page 15 of 16

ATTACHMENT 2 Confirmation of Receipt of Notice of Urgent Safety FSA/FSCA: 1822565-02-07-2014-001-C For confirmation of receipt of this notice, please complete and sign this document. Please send this form to your Zimmer local contact. Fax / Email: Don t hesitate to contact Zimmer if you need further details. This document confirms that you have received the Urgent Field Safety Notice on the product Polyethylene Implants from Gender Solutions Natural-Knee Flex, Natural-Knee, Natural-Knee II, MOST Options, and Apollo Systems. I certify that the relevant information was given to me by Zimmer, for the protection of the interests and safety of patients. (Printed Name of Surgeon) (Signature and Date) (Name of Hospital) Page 16 of 16

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