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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Steinmann Pins

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 Class 2 Recall
Zimmer Steinmann Pins
see related information
Date Posted June 26, 2009
Recall Status1 Terminated on November 12, 2009
Recall Number Z-1481-2009
Recall Event ID 52005
Product Classification Pin, Fixation, Smooth - Product Code HTY
Product Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69. Steinmann Pins are utilized in skeletal traction for alignment and reduction of long bone fractures as guide wires in hip pinning and for fracture alignment in certain other types of fractures.
Code Information Lot Number: 61156235.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The package contains pins with an incorrect diameter.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Zimmer, Inc. issued an "Urgent: Device Recall" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 37
Distribution Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.
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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