BEUDAMED
    FDA Recall Terminated

    ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.

    Recall: Z-1301-04 · Initiated June 28, 2004

    Recall

    Recall Number
    Z-1301-04
    Event Number
    29478
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 28, 2004
    Posted
    July 31, 2004
    Terminated
    October 5, 2005
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.

    Reason

    Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.

    Action

    Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.

    Distribution

    Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.

    Quantity

    3,252 units