# FDA recall Z-0179-2021

> **Bien-Air Surgery Sa** · Class II · device recall initiated 2020-09-11.

## 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.

## Distribution

US Nationwide distribution including in the states of CA, MI and MN.

## Key facts

- **Recall number:** Z-0179-2021
- **Recalling firm:** Bien-Air Surgery Sa
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-11
- **Report date:** 2020-10-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Le Noirmont, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0179-2021

## Citation

> AI Analytics. FDA recall Z-0179-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0179-2021. Source: US FDA. Licensed CC0.

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