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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 Recall
Zimmer NEXGEN Tibial Broach Impactor
see related information
Date Posted September 20, 2008
Recall Status1 Terminated on November 12, 2009
Recall Number Z-2301-2008
Recall Event ID 48717
Product Classification 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, Indiana 46580-2746
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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