# FDA recall Z-0172-2020

> **MEDTECH SAS** · Class I · device recall initiated 2019-09-10.

## Product

Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile.    The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

## Reason for recall

The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

## Distribution

Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.

## Key facts

- **Recall number:** Z-0172-2020
- **Recalling firm:** MEDTECH SAS
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2019-11-13
- **Termination date:** 2021-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montpellier, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0172-2020

## Citation

> AI Analytics. FDA recall Z-0172-2020. Retrieved 2026-09-26 from https://api.ai-analytics.org/recall/Z-0172-2020. Source: US FDA. Licensed CC0.

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