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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 Device Recall Zimmer Steinmann Pins see related information
Date Initiated by Firm May 01, 2009
Date Posted June 26, 2009
Recall Status1 Terminated 3 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
The package contains pins with an incorrect diameter.
FDA Determined
Cause 2
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.