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Bien-Air Surgery Sa recalls Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert
Recalled October 28, 2020 · FDA recall Z-0178-2021 · Bien-Air Surgery Sa
Hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. · FDA Class II
Units
Total US = 1120 foot pedals
Sold at
US Nationwide distribution including in the states of CA, MI and MN.
Description
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Product
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
Manufacturer(s)
Bien-Air Surgery Sa
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →