Class 2 Device Recall Versys Hip System femoral stem

• Date Initiated by Firm: January 07, 2003
• Date Posted: January 28, 2003
• Recall Status: Terminated on February 09, 2004
• Recall Number: Z-0474-03
• Recall Event ID: 25375
• 510(K)Number: K922071
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
• Product: Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 13, standard body. Cat. No. 7841-13-10.
• 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: The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
• FDA Determined Cause: Other
• Action: Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
• Distribution: United States, Australia and Canada.
• 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.