Reported Oct 28, 2020 · Ongoing
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that…
Bien-Air Surgery Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bien-Air Surgery Sa · rue de l' ouest 2b · Le Noirmont, N/A · N/A
Is this the product you have?
- Bien-Air Surgery REF 1600686-001 SN *******
- OSSEOSTAP Footcontrol - Product Usagean active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery
- Lot codes and dates
- Model 1600686 / Catalog
- number 1600686-001 Serial Numbers
18D000618D000718D000818D000918D001018D001318D001418D001518D001618D001718D001818D001918D002018D002118D002218D002318D002418D002518D002618D002718D002818D002918D003016A000516A000916A001016A001116A001417D001117G0006
- Amount recalled
- Total US = 1120 foot pedals
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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