Recall Z-0627-2013 ยท FWZ Operating Room Accessories Table Tray
Maquet Inc.
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.
| Date | Jan 3, 2013 (initiated Nov 2, 2012) |
| Status | Terminated |
| Reason | There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table. |
| Root cause | Device Design |
| Action | Maquet sent Urgent Product Field Correction letters/Field Correction Confirmation Form dated November 2, 2012 on November 15, 2012, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a MAQUET authorized Service Technicians would contact them to arrange an appointment to assess their device and to replace the release lever at no cost to them at their facility. Customers were asked to completed and return the enclosed confirmation form, acknowledging their receipt and understanding |
| Quantity | 63 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.