Recall Z-2039-2013— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-06-07, terminated 2014-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 00597502020 Provisional AC ART SURF PROV 12/PUR 20, Rx, Sterile; 00597502023 Provisional AC ART SURF PROV 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.. 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.

Recalling firm

Zimmer, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-06-07

Terminated

2014-12-15

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.