Recall Z-0627-2013— Maquet Inc.
Class II · Terminated
Class II FDA medical device recall by Maquet Inc., initiated 2012-11-02, terminated 2013-08-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table..
- Recalling firm
- Maquet Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-02
- Terminated
- 2013-08-21
- Firm location
- Wayne, NJ, United States
Product description
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.
Reason for recall
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Data sourced from openFDA. This site is unofficial and independent of the FDA.