Class II — Maquet Inc.
| Recalling firm | MAQUET (Suzhou) Co., Ltd |
|---|---|
| Registered facility | MAQUET (SUZHOU) CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table. |
| 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. |
| 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. |
| Initiated | 2012-11-02 |
| Classified | 2013-01-03 |
| Terminated | 2013-08-21 |
| Recall number | Z-0627-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Inc. (Z-0627-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63878/
Alerts for MAQUET (Suzhou) Co., Ltd
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.