BEUDAMED
    FDA Recall Terminated

    Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.

    Recall: Z-1411-04 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-1411-04
    Event Number
    29565
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    August 28, 2004
    Terminated
    October 5, 2004
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.

    Reason

    The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.

    Action

    Consignees were notified to inspect the devices for the defect via letter dated and faxed 7/12/04. A second letter issued 7/15/04 instructing consignees NOT to inspect the product, but to return all units.

    Distribution

    United States.

    Quantity

    79