Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL… — Class II medical device recall Z-0177-2021
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-0177-2021 |
|---|---|
| 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 | 16A0015, 16A0016, 16G0024, 16I0007, 16I0026, 16I0027, 16I0028, 16I0029, 16K0027, 17A0009, 17B0008, 17B0009, 17B0010, 17B0011, 17B0012, 17B0013, 17B0039, 17B0040, 17B0041, 17B0049, 17B0050, 17C0012, 17C0013, 17E0033, 17G0004 and 119 more |
| Model numbers | 1600517, 1600517-001 |
Product
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
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-0177-2021. 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.