Recall Z-2025-2013— 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: 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM, Rx, Sterile; 90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM, Rx, Sterile; 90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM, 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.