Description of affected product Reference Affected Lot Numbers Integra Licox Test Set BC10R ; ; ; ;

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1 To the attention of Medical Device Vigilance responsible / Central Pharmacy / BioMedical Engineer Subject: URGENT VOLUNTARY RECALL NOTIFICATION LETTER Medical device: Integra Licox Test Set (BC10R) used & provided with the following Integra Monitors: Licox CMP Tissue Oxygen Monitoring System (AC3.1_EU); Integra Licox Tissue Oxygen Monitor (LCX02); Integra Licox Tissue Oxygen Monitor (LCX02R); and the Licox Probe Cable Kits (BC10 and BC10RECON). Saint Priest, April 15, 2014 Reference: BC10R Legal Manufacturer of BC10R: GMS (Gesellschaft für medizinische Sondentechnik mbh), Dorfstraße 2, Mielkendorf, Germany Affected lot numbers: please refer to table herein below. Dear Customer, Integra LifeSciences Corporation (Integra) has identified that there may be the possibility that some lots of Integra Licox Test Set (reference: BC10R) provide an erroneous 'calibration test failure' message when they are used to control calibration of the Integra Licox Tissue Oxygen Monitors (references: AC3.1_EU; LCX02; LCX02R). When those lots of Integra Licox Test Set (reference: BC10R) are used, Licox Tissue Oxygen Monitor (LCX02/LCX02R) will display an error message while Licox CMP Tissue Oxygen Monitoring System (AC3.1_EU) may provide an erroneous out of range result. This error message and/or erroneous out of range result is due only to Integra Licox Test Set (reference: BC10R) and is not due to Integra Licox Tissue Oxygen Monitors (references: AC3.1_EU; LCX02; LCX02R). Thus, your monitors are not affected by this notification. Integra Licox Test Sets with the affected Lot Numbers were manufactured from May 2013 to December 2013 There have been no reports of patient injury or adverse health consequences associated with the above. Out of an abundance of caution, Integra is voluntarily recalling specific lot numbers and notifying you of this recall. Please note that Integra Licox Test Set (reference: BC10R) are also provided with Integra Licox Tissue Oxygen Monitors (references: AC3.1_EU; LCX02; LCX02R) and Licox Probe Cable Kits (BC10 and BC10RECON), so if you purchased one or more monitors from the serials affected below, you have to follow the steps described hereinafter. These monitors are not affected by this recall and work properly, only the Integra Licox Test Set (reference: BC10R) is affected. Thus, you do not have to return your monitor. You are notified of this recall as our records indicate that you have purchased an Integra Licox Test Set and/or Integra Licox Tissue Oxygen Monitor. Description of affected product Reference Affected Lot Numbers Integra Licox Test Set BC10R ; ; ; ; Recall Notification Letter - Page 1 on 3

2 Picture 1: Integra Licox Test Set (reference: BC10R) Integra is kindly asking you to do the following: 1. We kindly ask you to examine your inventory to determine if you have Integra Licox Test Set(s) (reference: BC10R) (as depicted on picture 1 hereinbefore). If so, please quarantine them. If you have also Integra Licox Tissue Oxygen Monitor(s) (references: AC3.1_EU; LCX02; LCX02R) and/or Integra Licox Probe Cable Kit (BC10 and BC10RECON), please refer to the table herein after to know if you have to check your inventory: Products that contain Integra Licox Test Set Licox CMP Tissue Oxygen Monitoring System Reference AC3.1_EU Serial numbers 2161; 816E; 817E; 1507; 1210; 2068; 2073; 1469; 885E; 895E; 929E; 1470; 1684; 1844; 1726; 1709; 1429; 1604 Integra Licox PtO2 Monitor LCX Integra Licox PtO2 Monitor LCX02R ; ; Licox Probe Cable Kit BC Licox Probe Cable Kit BC10RECON Once the audit of your inventory achieved, please complete the attached recall acknowledgement & return form: - If you do NOT have an affected lot number on the list, you can continue to use your Integra Licox Test Set(s). Tick the box: I do not have the affected product with affected Lot Numbers in my inventory. - If you do have product(s) on the affected lot number list, you must remove them from use and put them in quarantine. Tick the box: I do have affected product(s) in my inventory. Please record the total quantity corresponding to the lot number(s) you have. 3. Complete the other information on the recall acknowledgement & return form and return the form promptly as indicated on the form. When your form is received, and if you have noted you have affected product(s), our Customer Service will contact you and provide directions to return the product(s) and sending replacement products. The receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We also recommend that you keep a copy of this notification and a signed copy of the Recall Notification Letter - Page 2 on 3

3 acknowledgement form for your records. National Competent Authorities may perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action being taken. Please note that your National Competent Authority has been alerted of this recall. Thank you for your cooperation with this Recall and for returning the attached Recall Acknowledgement and Return Form. For any questions or concerns, please contact Jean-Charles Moncenis at the following address: Sincerely, Jean-Charles MONCENIS Senior Project Manager - Regulatory Affairs Neurosurgery Products Division Europe, Middle-East & Africa Recall Notification Letter - Page 3 on 3

4 RECALL ACKNOWLEDGMENT AND RETURN FORM Medical device: Integra Licox Test Set (BC10R) used & provided with the following Integra Monitors: Licox CMP Tissue Oxygen Monitoring System (AC3.1_EU); Integra Licox Tissue Oxygen Monitor (LCX02); Integra Licox Tissue Oxygen Monitor (LCX02R); and the Licox Probe Cable Kits (BC10 and BC10RECON). Reference: BC10R Legal Manufacturer of BC10R: GMS (Gesellschaft für medizinische Sondentechnik mbh), Dorfstraße 2, Mielkendorf, Germany Affected lot numbers: please refer to table herein below. Please Complete and Return Promptly Please fill out this form and return by or fax: By fax/telecopy: +33 (0) Or by I have received, read and understood the information provided in the Integra Recall notification regarding Integra Licox Test Set. My inventory has been reviewed, including additional products mentioned in the Integra Recall notification and the results are as follow (please tick the appropriate answer): Yes, I do have affected product(s) in my inventory. Please circle affected lot(s) and indicate quantity in the table below: Description of Affected Lot Reference affected product Numbers Integra Licox Test Set BC10R Quantity x x x x x With this form, No, I do not have the affected product with affected Lot Numbers in my inventory. - I confirm that I have received this Recall notification and that I intend to fully comply with it; - I confirm that this Recall notification has been circulated to all affected users and to appropriate people within my healthcare facility; - I ensure that all the affected products are being quarantined and will be shipped back to Integra. Please complete contact point details on next page. Recall acknowledgment and return form - Page 1 on 2

5 Contact point details Customer/Site Name Customer Contact Name Street Address City, Country, Postal Code Telephone Fax Signature Recall acknowledgment and return form - Page 2 on 2