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Bien-Air Surgery Sa recalls Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has
Recalled October 28, 2020 · FDA recall Z-0180-2021 · 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
N/A
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
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.
Manufacturer(s)
Bien-Air Surgery Sa
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →