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.
Published August 28, 2013 · Recall initiated: June 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the country of Japan.
- Lot
- all codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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