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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Reverse Shoulder System

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 Class 2 Recall
Trabecular Metal Reverse Shoulder System
see related information
Date Posted March 29, 2007
Recall Status1 Terminated on May 04, 2007
Recall Number Z-0675-2007
Recall Event ID 37365
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.
Code Information Lot 60605829.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Zimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer.
Quantity in Commerce 4
Distribution California, Ohio and Texas.
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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