Class 2 Device Recall

• Date Initiated by Firm: January 06, 2003
• Date Posted: January 23, 2003
• Recall Status: Terminated on December 04, 2003
• Recall Number: Z-0461-03
• Recall Event ID: 25257
• 510(K)Number: k012793
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
• Product: Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03
• Code Information: all lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E. Main St.; Warsaw IN 46580
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: Compression test results are not in accordance with device approval submission
• FDA Determined Cause: Other
• Action: Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
• Distribution: United States.
• 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.