BEUDAMED
    FDA Recall Terminated

    ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13501 ASSEMBLED IN MEXICO ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.

    Recall: Z-2282-2010 · Initiated December 18, 2008

    Recall

    Recall Number
    Z-2282-2010
    Event Number
    52030
    Firm
    ConMed Electrosurgery
    FEI Number
    3004491689
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 18, 2008
    Posted
    August 25, 2010
    Terminated
    October 22, 2010
    Address
    14603 E Fremont Ave, Centennial, CO, 80112-4251

    Description

    ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13501 ASSEMBLED IN MEXICO ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.

    Reason

    The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.

    Action

    An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.

    Distribution

    Nationwide and International

    Quantity

    Dom: 1375 cs (13750 units); Int'l: 1427 cs (14270 units)