FDA recall Z-0179-2021

Bien-Air Surgery Sa · Class II · device

Product

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.

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-0179-2021