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Bien-Air Surgery Sa recalls Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has bee
Recalled October 28, 2020 · FDA recall Z-0179-2021 · 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
Total US = 1120 foot pedals
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
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.
Manufacturer(s)
Bien-Air Surgery Sa
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →