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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 21
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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