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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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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.

Product Detail

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