BEUDAMED
    FDA Recall Terminated

    Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.

    Recall: Z-0452-2008 · Initiated November 2, 2007

    Recall

    Recall Number
    Z-0452-2008
    Event Number
    45867
    Firm
    ConMed Electrosurgery
    FEI Number
    3004491689
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 2, 2007
    Posted
    December 11, 2007
    Terminated
    March 31, 2010
    Address
    14603 E. Fremont Avenue, Centennial, CO, 80112

    Description

    Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.

    Reason

    Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

    Action

    Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.

    Distribution

    Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.

    Quantity

    11,319 cases (476,160 units)