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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

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.
Recall Number Z-0627-2013
Classification Class II
Code Info Class I exempt Device Listing Number A922956
Product Distributed Qty 63 devices
Reason For Recall There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.

Event Detail

Event Id 63878
Product Type Devices
Status Ongoing
Recalling Firm Maquet Inc.
City Wayne
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-02
Initial Firm Notification of Consignee or Public Letter
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.