Device product
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Z-2019-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 65413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192,355 all devices
- Official record key
device-enforcement:Z-2019-2013
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