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Recall Observatory FDA recall evidence

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

September 11, 2020

Class II

Product summary

Firm
Bien-Air Surgery Sa
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

    reason.no_named_rule · v1.0.0

    The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.