FDA-Device2020-10-28Class II
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
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
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2021Don't want to check this manually?
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