BEUDAMED
    FDA Enforcement Class II Terminated

    4.5 mm Malleolar Screw Sterile zimmer

    Recall: Z-2250-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2250-2014
    Event ID
    68819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 22, 2014
    Classification Date
    August 15, 2014
    Termination Date
    June 18, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    4.5 mm Malleolar Screw Sterile zimmer

    Reason

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

    Code Info

    Item Number 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08

    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