Class 2 Device Recall Zimmer M/DN Intramedullary Fixation

• Date Initiated by Firm: June 26, 2006
• Date Posted: August 03, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-1342-06
• Recall Event ID: 35784
• Product Classification: bone screw - Product Code NDJ
• Product: Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55 (00225309555).
• Code Information: Lots 17036400, 17658000, 17734800, 17887700, 18279700, 21846200, 22983000 and 23083900.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
• FDA Determined Cause: Other
• Action: Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
• Quantity in Commerce: 310 total for all catalog numbers
• Distribution: Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
• 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.