Device product
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.
Z-0176-2021
Product summary
- Event
- Event 86419
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Total US = 1120 foot pedals
- Official record key
device-enforcement:Z-0176-2021
Official wording
Reason: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Code information: Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
Distribution pattern: US Nationwide distribution including in the states of CA, MI and MN.
Derived failure modes
-
Unknown
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.