—#118931

Product

00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: all codes

Why it was 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

Root cause (FDA determination)

Labeling design

Action the firm took

Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Japan.

Timeline

Recall initiated: 2013-06-07
Posted by FDA: 2013-08-22
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.