Class 2 Device Recall Zimmer Trilogy Acetabular Shell

• Date Initiated by Firm: October 19, 2007
• Date Posted: March 19, 2008
• Recall Status: Terminated on May 21, 2008
• Recall Number: Z-0620-2008
• Recall Event ID: 45479
• 510(K)Number: K934765
• Product Classification: Hip Prosthesis Component - Product Code LPH
• Product: Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.
• Code Information: Lot Number: 26208600; exp. 2013-02.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
• FDA Determined Cause: Process control
• Action: Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.
• Quantity in Commerce: 31
• Distribution: Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.
• 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.

• 510(K) Database: 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.