Bien-Air Surgery Sa recalls Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been d…

Recall date

September 11, 2020

Source

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

Recall number

Z-0179-2021

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

Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.