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Recall Observatory FDA recall evidence

Device product

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.

Z-0627-2013

November 02, 2012

Class II

Product summary

Firm
Maquet Inc.
Event
Event 63878
Status
Terminated
Classification
Class II
Quantity
63 devices
Official record key
device-enforcement:Z-0627-2013

Official wording

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

Code information: Class I exempt Device Listing Number A922956

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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