CLASS II Device recall · Reported 9 Jan 2013 · FDA Enforcement Report
Yuno Extension Table Device Maquet GmbH & Co. KG Kehler recalled
Maquet is recalling Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31, distributed nationwide in the US. The recall was initiated on 2 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0627-2013
- FDA event ID
- 63878
- Recalling firm
- Maquet, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2012
- FDA classified
- 3 Jan 2013
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2012 | Recall initiated by company | |
| 3 Jan 2013 | Classified by FDA | +62 days |
| 9 Jan 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg recalled?
Yes. Maquet recalled Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg on 2 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0627-2013.
Why was it recalled?
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Which lots are affected?
Class I exempt Device Listing Number A922956
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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