BEUDAMED
    FDA Recall Terminated

    ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.

    Recall: Z-1566-2010 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-1566-2010
    Event Number
    55189
    Firm
    ConMed Electrosurgery
    FEI Number
    3004491689
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 29, 2010
    Posted
    May 10, 2010
    Terminated
    September 27, 2010
    Address
    14603 E Fremont Ave, Centennial, CO, 80112-4251

    Description

    ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.

    Reason

    Electrosurgical pencil may remain activated or self activate after power switch is released.

    Action

    Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.

    Distribution

    Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.

    Quantity

    21,120 units (US), 21,400 units (Foreign)