BEUDAMED
    FDA Recall Terminated

    Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.

    Recall: Z-0985-03 · Initiated May 21, 2003

    Recall

    Recall Number
    Z-0985-03
    Event Number
    26386
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2003
    Posted
    July 8, 2003
    Terminated
    December 10, 2003
    Address
    4545 Creek Rd, Cincinnati, OH, 45242

    Description

    Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.

    Reason

    The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.

    Action

    The firm contacted their customers by FedEx on 5/21/2003.

    Distribution

    The product was shipped to hospitals and distributors located nationwide.

    Quantity

    8 units