Class 2 Device Recall Zimmer NEXGEN Tibial Broach Impactor

• Date Initiated by Firm: June 30, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-2301-2008
• Recall Event ID: 48717
• Product Classification: Broach Impactor - Product Code HWA
• Product: Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
• Code Information: All units.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-372-4487
• Manufacturer Reason for Recall: The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.
• Quantity in Commerce: 1439
• Distribution: Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
• 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.