FDA recall Z-0176-2021

Bien-Air Surgery Sa · Class II · device

Product

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

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-0176-2021