BEUDAMED
    FDA Recall Terminated

    Flexgard, off-the-shelf knee brace, product number 14761106

    Recall: Z-0658-03 · Initiated February 14, 2003

    Recall

    Recall Number
    Z-0658-03
    Event Number
    25659
    Firm
    De Royal Industries
    FEI Number
    2021791
    Product Code
    ITQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2003
    Posted
    March 19, 2003
    Terminated
    August 22, 2003
    Address
    870 Industrial Way, San Luis Obispo, CA, 93401

    Description

    Flexgard, off-the-shelf knee brace, product number 14761106

    Reason

    Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.

    Action

    The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed.

    Distribution

    ID, CA, NC, TX, SC, NM, GA and TN

    Quantity

    13