Affected Product: Polyethylene Implants from Gender Solutions Natural-Knee Flex, Natural-Knee, Natural-Knee II, MOST Options, and Apollo Systems
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- Lisa Lang
- 8 years ago
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Transcription
1 March 19, 2014 To: Surgeons Subject: URGENT MEDICAL DEVICE RECALL NOTIFICATION Zimmer reference: 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, 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
2 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 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
3 ATTACHMENT 1 Item Lot General Description MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Tibia Insert MOST Options System (MOST) Proximal Tibia Insert Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 3 of 16
4 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 4 of 16
5 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Page 5 of 16
6 Gender Solutions Natural-Knee Flex System Metal Backed Patella Component Natural-Knee II System All Poly Patella Natural-Knee II System All Poly Patella Natural-Knee II System All Poly Patella Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Page 6 of 16
7 Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Unicompartmental Tibia Inserter Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee II System Metal Backed Patella Component Natural-Knee Congruent Tibial Insert with Screw Natural-Knee Congruent Tibial Insert with Screw Natural-Knee Congruent Tibial Insert with Screw Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Page 7 of 16
8 Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II System All Poly Ultra Congruent Tibia Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Page 8 of 16
9 Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II Rotating Platform Ultra Congruent Tibial Insert Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Page 9 of 16
10 Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II System All Poly Congruent Tibia Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Page 10 of 16
11 Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Posterior Stabilized (P.S) Tibial Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Page 11 of 16
12 Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Page 12 of 16
13 Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Constrained Knee System Tibia Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Page 13 of 16
14 Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Insert Apollo Knee System Patella Component Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee Tibial Baseplate/Knee Congruent Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Knee System Posterior Stabilized Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Page 14 of 16
15 Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Apollo Revision/Constrained Knee System Constrained Tibial Insert Page 15 of 16
16 ATTACHMENT 2 Confirmation of Receipt of Notice of Urgent Safety FSA/FSCA: C For confirmation of receipt of this notice, please complete and sign this document. Please send this form to your Zimmer local contact. Fax / 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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