Device product
00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Z-2026-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192,355 all devices
- Official record key
device-enforcement:Z-2026-2013
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