# FDA recall Z-0105-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2016-05-27.

## Product

ROSA Brain 3.0  Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

## Reason for recall

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

## Distribution

Worldwide Distribution - US (DC) and Internationally to   Australia and France.

## Key facts

- **Recall number:** Z-0105-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-05-27
- **Report date:** 2017-11-29
- **Termination date:** 2020-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2018

## Citation

> AI Analytics. FDA recall Z-0105-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0105-2018. Source: US FDA. Licensed CC0.

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