FDA-Device2013-08-28Class II
00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Zimmer, Inc.
Hazard
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
Sold states
Worldwide Distribution-USA (nationwide) and the country of Japan.
Affected count
192,355 all devices
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2014-2013Don't want to check this manually?
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