# FDA recall Z-0115-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2016-04-08.

## Product

ROSA  Surgical Device 2.5.8

## Reason for recall

Potential for software to change the final tool orientation for the command position without command.

## Distribution

AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA  Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

## Key facts

- **Recall number:** Z-0115-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-04-08
- **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-0115-2018

## Citation

> AI Analytics. FDA recall Z-0115-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0115-2018. Source: US FDA. Licensed CC0.

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