Class 2 Device Recall Zimmer Durom

• Date Initiated by Firm: September 26, 2007
• Date Posted: November 29, 2007
• Recall Status: Terminated on June 04, 2008
• Recall Number: Z-0275-2008
• Recall Event ID: 45326
• 510(K)Number: K070292
• Product Classification: Prosthesis Resurfacing (Hip, Femoral) - Product Code KXA
• Product: Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.
• Code Information: Lot 2376766.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E. Main St.; Warsaw IN 46580-2304
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
• FDA Determined Cause: Packaging process control
• Action: Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
• Quantity in Commerce: 1
• Distribution: Nationwide
• 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 = KXA and Original Applicant = ZIMMER GMBH