Class 2 Device Recall Coonrad/Morrey total elbow.

• Date Initiated by Firm: March 16, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 26, 2004
• Recall Number: Z-0768-04
• Recall Event ID: 28576
• Product Classification: Prosthesis, Elbow, Constrained, Cemented - Product Code JDC
• 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.
• Code Information: Lots 60039453, 60039454, 60040852 and 60041552.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.
• FDA Determined Cause: Other
• Action: 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.
• Distribution: United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.