BEUDAMED
    FDA Enforcement Class II 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 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0359-2016
    Event ID
    72586
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    November 5, 2015
    Classification Date
    December 1, 2015
    Termination Date
    May 24, 2018
    Address
    525 French Rd, Utica, NY, 13502-5945, United States

    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.

    Code Info

    Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006

    Distribution

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

    Quantity

    9 devices