FDA recall Z-0180-2021

Bien-Air Surgery Sa · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2020-09-11
Report date
2020-10-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Le Noirmont, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2021