Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEDTECH ROSA Brain 3.0 The device is intended for the Recalled by Zimmer Biomet, Inc. Due to Unapproved change made by the supplier.

Date: February 27, 2017
Company: Zimmer Biomet, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.

Affected Products

MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.

Quantity: 16

Why Was This Recalled?

Unapproved change made by the supplier.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer Biomet, Inc.

Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report