BEUDAMED
    FDA Recall Terminated

    Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

    Recall: Z-0815-03 · Initiated March 17, 2003

    Recall

    Recall Number
    Z-0815-03
    Event Number
    25940
    Firm
    Ossur North America Inc
    FEI Number
    1000519909
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2003
    Posted
    May 14, 2003
    Terminated
    April 14, 2004
    Address
    27412 Laguna Hills Dr, Aliso Viejo, CA, 92656

    Description

    Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

    Reason

    Knee frame defect lead to breakage and injury. Knee bolt end came loose.

    Action

    Firm called customers by phone and sent recall letters 3/17/2003.

    Distribution

    Nationwide.

    Quantity

    261