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. |
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