Device product
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Z-2016-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192,355 all devices
- Official record key
device-enforcement:Z-2016-2013
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