Bien-Air Surgery Sa recalls Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to me…
- Recall date
- September 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0176-2021
- FDA classification
- Class II
- Brand / firm
- Bien-Air Surgery Sa
- Sold / distributed
- US Nationwide distribution including in the states of CA, MI and MN.
Why it was recalled
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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