BEUDAMED
    FDA Recall Terminated

    VSP Shock Module (as part of a prosthetic foot).

    Recall: Z-1083-04 · Initiated June 15, 2004

    Recall

    Recall Number
    Z-1083-04
    Event Number
    29386
    Firm
    Ossur North America Inc
    FEI Number
    1000519909
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 15, 2004
    Posted
    July 20, 2004
    Terminated
    June 17, 2005
    Address
    27412 Aliso Viejo Pkwy, Aliso Viejo, CA, 92656-3371

    Description

    VSP Shock Module (as part of a prosthetic foot).

    Reason

    Flawed shock module might cause breakage causing patient to fall.

    Action

    Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.

    Distribution

    Nationwide.

    Quantity

    37