# FDA recall Z-0102-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2014-02-14.

## 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

## Reason for recall

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

## Distribution

OH, MI and TX

## Key facts

- **Recall number:** Z-0102-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-02-14
- **Report date:** 2017-11-22
- **Termination date:** 2020-09-16

- **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-0102-2018

## Citation

> AI Analytics. FDA recall Z-0102-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0102-2018. Source: US FDA. Licensed CC0.

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