BEUDAMED
    FDA Recall Terminated

    UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

    Recall: Z-0735-2013 · Initiated December 27, 2012

    Recall

    Recall Number
    Z-0735-2013
    Event Number
    63981
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    December 27, 2012
    Posted
    January 24, 2013
    Terminated
    May 14, 2018
    Address
    525 French Road, Utica, NY, 13502

    Description

    UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

    Reason

    ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.

    Action

    ConMed sent an Urgent Field Safety Notice dated January 7, 2013, and Business Reply Form to all affected customers via USPS Priority Mail. International notices were sent via FedEx International Priority on December 27, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 Customer were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.

    Quantity

    313,190 (total for all devices)