FDA-Device2013-08-28Class II
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/
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
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, 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-2024-2013Don't want to check this manually?
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