# FDA recall Z-0180-2021

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

## Product

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

## 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-0180-2021
- **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-0180-2021

## Citation

> AI Analytics. FDA recall Z-0180-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0180-2021. Source: US FDA. Licensed CC0.

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