Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
FDA Recall Z-0531-2011 · Posted 2010-12-02
Advertisement
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-09-15
Date Terminated2011-07-27
Product Quantity192 all sizes of 5996.
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement