Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52.
FDA device recall Z-0534-2011 · posted 2010-12-02 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 158 all sizes of 5764
- Distribution
- US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.
- Date initiated
- 2010-09-15
- Date posted
- 2010-12-02
- Date terminated
- 2011-07-27
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS (K060370) | Zimmer, Inc. | 2006-04-28 |
| NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES (K960279) | Zimmer, Inc. | 1996-04-26 |