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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NEXGEN Tibial Broach Impactor

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  Class 2 Device Recall Zimmer NEXGEN Tibial Broach Impactor see related information
Date Initiated by Firm June 30, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
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 2
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.