Z-0627-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2013
- Initiation Date
- November 2, 2012
- Termination Date
- August 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 devices
Product 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 for Recall
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
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.
Code Information
Class I exempt Device Listing Number A922956