Class 2 Device Recall Zimmer VERSYS

• Date Initiated by Firm: August 02, 2006
• Date Posted: August 31, 2006
• Recall Status: Terminated on May 04, 2007
• Recall Number: Z-1468-06
• Recall Event ID: 35943
• 510(K)Number: K961378
• Product Classification: hip prosthesis - Product Code LWJ
• Product: Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).
• Code Information: Lots 60454196, 60454197, 60454198, 60454199, 60465016 and 60465017.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Connie Morgan; 800-846-4637
• Manufacturer Reason for Recall: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
• Quantity in Commerce: 181 of all devices
• Distribution: Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
• 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 = LWJ and Original Applicant = ZIMMER, INC.