BEUDAMED
    FDA Recall Terminated

    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.

    Recall: Z-0359-2016 · Initiated November 5, 2015

    Recall

    Recall Number
    Z-0359-2016
    Event Number
    72586
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 5, 2015
    Posted
    December 1, 2015
    Terminated
    May 24, 2018
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.

    Reason

    Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.

    Action

    On November 4, 2015, ConMed Corporation distributed Urgent Device Recall Notification letters dated November 5, 2015 to their customers via overnight courier service. Customers should stop the use of these devices immediately. The recall notice recipient should contact all organizations within their facility and any other facilities that may have received the affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Customers with questions can call Patricia Cotter, ConMed Recall Coordinator 315-624-3237 (8AM - 5PM EST, Monday through Friday), or fax to 315-624-3225 or email [email protected]. Customers who have any of the devices subject to recall (listed on the recall notice-attachment I) should immediately contact their sales representative. The sales representative will deliver a replacement unit to your facility and will pick up and return the recalled devices to ConMed Corporation. If you are unable to reach your sales representative, please contact Patricia Cotter at the numbers above. If you do not have any devices to return, customers should complete the Business Reply Form (attachment II), indicating you have no devivces and fax it to 315-624-3225, Attn: Patricia Cotter.

    Distribution

    Distributed in the states of CA, and TX and in the country of Mexico.

    Quantity

    9 devices