Class 2 Device Recall Maquet Yuno Extension Table Device

• Date Initiated by Firm: November 02, 2012
• Date Posted: January 03, 2013
• Recall Status: Terminated on August 21, 2013
• Recall Number: Z-0627-2013
• Recall Event ID: 63878
• Product Classification: Accessories, operating-room, table (kit) - Product Code FWZ
• Product: 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.
• Code Information: Class I exempt Device Listing Number A922956
• Recalling Firm/ Manufacturer: Maquet Inc.; 45 Barbour Pond Drive; Wayne NJ 07470
• For Additional Information Contact: Ms. Susan Mandy; 973-709-7660
• Manufacturer Reason for Recall: There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.