BEUDAMED
    FDA Recall Terminated

    4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer

    Recall: Z-2251-2014 · Initiated July 22, 2014

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    Recall

    Recall Number
    Z-2251-2014
    Event Number
    68819
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 22, 2014
    Posted
    August 16, 2014
    Terminated
    June 18, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer

    Reason

    Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

    Action

    On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.

    Distribution

    National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE

    Quantity

    47,682 units total