Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
00595203110 Articular Surface XLPE CR ART SURF 3 Recalled by Zimmer, Inc. Due to Surgeons are implanting components of the NexGen Cruciate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.
Affected Products
00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Quantity: 192,355 all devices
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report