# FDA recall Z-0177-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2015-10-29.

## Product

Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.

## Reason for recall

A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.

## Distribution

Worldwide Distribution including France and Germany

## Key facts

- **Recall number:** Z-0177-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-10-29
- **Report date:** 2017-12-06
- **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-0177-2018

## Citation

> AI Analytics. FDA recall Z-0177-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0177-2018. Source: US FDA. Licensed CC0.

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