BEUDAMED
    FDA Enforcement Class II Terminated

    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

    Recall: Z-1605-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1605-2014
    Event ID
    68017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    March 19, 2014
    Classification Date
    May 9, 2014
    Termination Date
    April 14, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

    Reason

    During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

    Code Info

    Model #: 00-1773-002-00 through 00-1773-008-00

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.

    Quantity

    546 units