# FDA recall Z-0638-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-05-01.

## Product

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device.    Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.

## Reason for recall

Robot arm being sent to the wrong position

## Distribution

Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.

## Key facts

- **Recall number:** Z-0638-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-01
- **Report date:** 2018-02-28
- **Termination date:** 2020-07-13

- **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-0638-2018

## Citation

> AI Analytics. FDA recall Z-0638-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0638-2018. Source: US FDA. Licensed CC0.

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