| Class 2 Device Recall Zimmer NexGen LPS Flex Gender | |
Date Initiated by Firm | September 15, 2010 |
Date Posted | December 02, 2010 |
Recall Status1 |
Terminated 3 on July 27, 2011 |
Recall Number | Z-0536-2011 |
Recall Event ID |
57178 |
510(K)Number | K060370 K960279 |
Product Classification |
knee prosthesis femoral component - Product Code JWH
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Product | Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52. |
Code Information |
61488033, 61488035, 61499888 and 61499891. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | Cheryl Trease 574-267-6131 |
Manufacturer Reason for Recall | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all devices have nonconforming geometry. |
FDA Determined Cause 2 | Process design |
Action | The firm sent URGENT DEVICE CORRECTION AND REMOVAL notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by surgeons. |
Quantity in Commerce | 158 all sizes of 5764 |
Distribution | US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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