—#32157

Product

Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-02.

FDA product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lots 60039453, 60039454, 60040852 and 60041552.

Why it was recalled

right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.

Recalling firm

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

Distribution

Distribution pattern: United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.

Timeline

Recall initiated: 2004-03-16
Posted by FDA: 2004-07-20
Terminated: 2004-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.