BEUDAMED
    FDA Recall 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 · Initiated November 2, 2012

    Recall

    Recall Number
    Z-0627-2013
    Event Number
    63878
    Firm
    Maquet Inc.
    FEI Number
    3008355164
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 2, 2012
    Posted
    January 3, 2013
    Terminated
    August 21, 2013
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    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.

    Action

    Maquet sent Urgent Product Field Correction letters/Field Correction Confirmation Form dated November 2, 2012 on November 15, 2012, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a MAQUET authorized Service Technicians would contact them to arrange an appointment to assess their device and to replace the release lever at no cost to them at their facility. Customers were asked to completed and return the enclosed confirmation form, acknowledging their receipt and understanding of the communication, in the enclosed postage prepaid envelope, by e-mailing a scanned copy to [email protected] or via fax at 973-709-6508. For questions customers were instructed to call MAQUET Technical Support at 800-777-4222, Press option2, followed by option 2. For questions regarding this recall call 973-709-7660.

    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