BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0706-2020 · Initiated November 21, 2019

    Recall

    Recall Number
    Z-0706-2020
    Event Number
    84364
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    ITQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 21, 2019
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    DeRoyal issued their recall on 11/21/19 by email and letter to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Distributors were asked to further notify their customers. They were asked to do this directly or to provide us with a customer listing and we would notify them.

    Distribution

    Nationwide, Australia, India, Saudi Arabia

    Quantity

    2789 units