Bien-Air Surgery Sa recalls Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that conver…

Recall date

September 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0178-2021

FDA classification

Class II

Brand / firm

Bien-Air Surgery Sa

Sold / distributed

US Nationwide distribution including in the states of CA, MI and MN.

Why it was recalled

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.