# FDA recall Z-0160-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2014-11-06.

## Product

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

## Reason for recall

Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

## Distribution

US distribution in AR, GA, OH, MI, and TX.

## Key facts

- **Recall number:** Z-0160-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-11-06
- **Report date:** 2017-11-29
- **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-0160-2018

## Citation

> AI Analytics. FDA recall Z-0160-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0160-2018. Source: US FDA. Licensed CC0.

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