BEUDAMED
    FDA Recall 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.

    Recall: Z-1481-2009 · Initiated May 1, 2009

    Recall

    Recall Number
    Z-1481-2009
    Event Number
    52005
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 1, 2009
    Posted
    June 26, 2009
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    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.

    Reason

    The package contains pins with an incorrect diameter.

    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.

    Distribution

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

    Quantity

    37