BEUDAMED
    FDA Recall Terminated

    Proven Porous CR Femur. Implantable orthopedic device

    Recall: Z-0496-05 · Initiated September 24, 2004

    Recall

    Recall Number
    Z-0496-05
    Event Number
    30287
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2004
    Posted
    February 3, 2005
    Terminated
    February 7, 2005
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    Proven Porous CR Femur. Implantable orthopedic device

    Reason

    Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch

    Action

    The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.

    Distribution

    The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.

    Quantity

    105 units