Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC — Class II medical device recall Z-0176-2021
Ongoing recall by Bien-Air Surgery Sa, reported 2020-10-28, distributed nationwide. The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
| Recall number | Z-0176-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bien-Air Surgery Sa, Le Noirmont, N/A, Switzerland |
| Recall initiated | 2020-09-11 |
| Classified | 2020-10-21 |
| Reported by FDA | 2020-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,120 foot |
| Serial numbers | 16C0017, 16F0013, 16I0009, 16K0017, 17F0039, 17I0015, 17L0013 |
| Model numbers | 1600407, 1600407-001 |
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.
Reason for recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0176-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.