BEUDAMED
    FDA Enforcement Class II Terminated

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    Recall: Z-1179-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1179-2019
    Event ID
    82451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus ACMI, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 8, 2019
    Classification Date
    April 17, 2019
    Termination Date
    May 8, 2020
    Address
    2925 Appling Rd, N/A, Bartlett, TN, 38133-3901, United States

    Description

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    Reason

    Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

    Code Info

    All lot numbers

    Distribution

    Nationwide Foreign: Germany,Japan, Singapore

    Quantity

    502 OUS