Bien-Air Surgery Sa recalls Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to co…

Recall date

September 11, 2020

Source

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

Recall number

Z-0177-2021

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 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.