Device product
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Z-1999-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192,355 all devices
- Official record key
device-enforcement:Z-1999-2013
Official wording
Reason: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Code information: all codes
Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Japan.
Derived failure modes
-
Unknown
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d