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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen

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 Class 2 Recall
NexGen
see related information
Date Posted March 28, 2007
Recall Status1 Terminated on December 04, 2007
Recall Number Z-0647-2007
Recall Event ID 37069
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272518.
Code Information Lot 97000414.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The device was cut to an incorrect angle, which may result in an incorrect bone cut.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Product was removed from customer location during visit on 10/10/2006.
Quantity in Commerce 1
Distribution One medical facility in Michigan.
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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