FDA-Device2020-10-28Class II
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.
Bien-Air Surgery Sa
Hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Sold states
US Nationwide distribution including in the states of CA, MI and MN.
Affected count
Total US = 1120 foot pedals
Manufactured in
rue de l' ouest 2b, N/A, Le Noirmont, N/A, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0179-2021Don't want to check this manually?
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