BEUDAMED
    FDA Recall Terminated

    ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    Recall: Z-0103-2007 · Initiated October 12, 2006

    Recall

    Recall Number
    Z-0103-2007
    Event Number
    36515
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 12, 2006
    Posted
    October 27, 2006
    Terminated
    August 30, 2012
    Address
    525 French Road, Utica, NY, 13502-5945

    Description

    ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    Reason

    The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws.

    Action

    On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.

    Distribution

    Worldwide

    Quantity

    38 units