Z-0627-2013Class II

Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437...

Name: Z-0627-2013 Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437...
Creator: Maquet Inc.
Published: 2012-11-02
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2012-11-02 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities... on 2012-11-02. FDA classified it as Class II and gives the reason as "There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0627-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Posted: 2013-01-03
Terminated: 2013-08-21
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: FWZ Operating Room Accessories Table Tray
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 tag: design
FDA 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 of the communication, in the enclosed postage prepaid envelope, by e-mailing a scanned copy to [email protected] 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.
Product codes and lots: Class I exempt Device Listing Number A922956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0627-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0627-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)