FDA-Device2020-10-28Class II
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.
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 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2021Don't want to check this manually?
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