# FDA recall Z-0161-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2014-06-04.

## Product

ROSA Surgical Device 2.5.8      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

Software corrections reactivating the cooperative endoscopy mode.

## Distribution

Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.

## Key facts

- **Recall number:** Z-0161-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-06-04
- **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-0161-2018

## Citation

> AI Analytics. FDA recall Z-0161-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0161-2018. Source: US FDA. Licensed CC0.

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