BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.

    Recall: Z-0627-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0627-2013
    Event ID
    63878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 9, 2013
    Initiation Date
    November 2, 2012
    Classification Date
    January 3, 2013
    Termination Date
    August 21, 2013
    Address
    45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States

    Description

    Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.

    Reason

    There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.

    Code Info

    Class I exempt Device Listing Number A922956

    Distribution

    Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.

    Quantity

    63 devices