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Terminated

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.

FDA Recall Z-1481-2009 · Posted 2009-06-26

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHTY
Date Initiated2009-05-01
Date Terminated2009-11-12
Product Quantity37

Reason for Recall

The package contains pins with an incorrect diameter.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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