Recalls / —

—#32155

Product

Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.

FDA product code

JDC — Prosthesis, Elbow, Constrained, Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K001989

Affected lot / code info

Lot 60039452.

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 #32155. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.