# FDA recall Z-2108-2018

> **MEDTECH SAS** · Class II · device recall initiated 2018-05-08.

## Product

ROSA(TM) Robotized Stereotactic Assistant, Version 2.5      ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

## Reason for recall

Replacement of units lacking an updated device approval.

## Distribution

US Distribution

## Key facts

- **Recall number:** Z-2108-2018
- **Recalling firm:** MEDTECH SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-08
- **Report date:** 2018-06-13
- **Termination date:** 2020-08-19

- **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-2108-2018

## Citation

> AI Analytics. FDA recall Z-2108-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2108-2018. Source: US FDA. Licensed CC0.

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