Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal — Class II medical device recall Z-0179-2021
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-0179-2021 |
|---|---|
| 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 | 16D0002, 16D0003, 16D0004, 16D0005, 16D0006, 16D0007, 16D0008, 16D0009, 16D0010, 16D0011, 16D0012, 16D0013, 16D0014, 16D0015, 16D0016, 16D0017, 16D0018, 16D0019, 16D0020, 16D0021, 16D0022, 16D0023, 16D0024, 16D0025, 16D0026 and 398 more |
| Model numbers | 1600983, 1600983-001, 5452-007-000 |
Product
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
Reason for recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Machine access
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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.