BEUDAMED
    FDA Recall Terminated

    ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    Recall: Z-1433-06 · Initiated March 27, 2006

    Recall

    Recall Number
    Z-1433-06
    Event Number
    35949
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2006
    Posted
    August 24, 2006
    Terminated
    April 27, 2012
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    Reason

    Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.

    Action

    On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.

    Distribution

    Worldwide

    Quantity

    5205 units