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.
This recall has been terminated (originally issued January 3, 2013).
- Company
- Maquet Inc.
- Recall Initiated
- November 2, 2012
- Posted
- January 3, 2013
- Terminated
- August 21, 2013
- Recall Number
- Z-0627-2013
- Quantity
- 63 devices
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
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.
Lot / Code Info
Class I exempt Device Listing Number A922956
Root Cause
Device Design
Action Taken
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 of the communication, in the enclosed postage prepaid envelope, by e-mailing a scanned copy to FieldActions@maquet.com or via fax at 973-709-6508. For questions customers were instructed to call MAQUET Technical Support at 800-777-4222, Press option2, followed by option 2. For questions regarding this recall call 973-709-7660.