{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114946", "product_res_number": "Z-0627-2013", "event_date_initiated": "2012-11-02", "event_date_posted": "2013-01-03", "recall_status": "Terminated", "event_date_terminated": "2013-08-21", "res_event_number": "63878", "product_code": "FWZ", "product_description": "Maquet Yuno Extension Table Device\nMaquet GmbH & Co. KG\nKehler Strabe 31\nBaden-Wuerttemberg\n76437 Rastatt,Germany \n\nUsed 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_info": "Class I exempt Device Listing Number A922956", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Inc.", "address_1": "45 Barbour Pond Drive", "city": "Wayne", "state": "NJ", "postal_code": "07470", "additional_info_contact": "Ms. Susan Mandy\n973-709-7660", "reason_for_recall": "There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.", "root_cause_description": "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.\nFor questions customers were instructed to call MAQUET Technical Support at 800-777-4222, Press option2, followed by option 2.\nFor questions regarding this recall call 973-709-7660.", "product_quantity": "63 devices", "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.", "openfda": { "k_number": [ "K810433", "K945415", "K871703", "K871823", "K871840", "K833624", "K840421", "K832472", "K865024", "K821029", "K904826", "K871804", "K882078", "K790674", "K760456", "K931037", "K842700", "K820291", 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