BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

    Recall: Z-0706-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0706-2020
    Event ID
    84364
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 25, 2019
    Initiation Date
    November 21, 2019
    Classification Date
    December 19, 2019
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

    Reason

    The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

    Code Info

    1) REF KB9000-01 Lot Numbers: 9798560, 49798543, 49976101, 49798578, 49976119, 50166762, 50166842, 50353058, 50353066, 50353074, 50353082, 50353091, 50353103, 50471126, 50575494, 50555223 2) REF 11-450A-00 Lot Numbers: 9798480, 50226649, 50226665, 49832318, 49976047, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675 3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594

    Distribution

    Nationwide, Australia, India, Saudi Arabia

    Quantity

    2789 units