Class II — Bien-Air Surgery Sa
| Recalling firm | Bien-Air Surgery SA |
|---|---|
| Registered facility | BIEN-AIR SURGERY SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| 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. |
| Quantity | Total US = 1120 foot pedals |
| Distribution | US Nationwide distribution including in the states of CA, MI and MN. |
| Initiated | 2020-09-11 |
| Classified | 2020-10-21 |
| Recall number | Z-0176-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bien-Air Surgery Sa (Z-0176-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86419/
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