Bien-Air Surgery Sa recalls Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System ha…

Recall date

September 11, 2020

Source

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

Recall number

Z-0180-2021

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

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.