BEUDAMED
    FDA Enforcement Class II Terminated

    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    Recall: Z-1296-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1296-2016
    Event ID
    73380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur H / F
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    February 24, 2016
    Classification Date
    March 31, 2016
    Termination Date
    August 15, 2016
    Address
    Grjothals 5, N/A, Reykjavik, N/A, N/A, Iceland

    Description

    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    Reason

    Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p

    Code Info

    Item No: B-122500020 B-122600020

    Distribution

    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV

    Quantity

    456