Class II — Potential Health Hazard

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

ROSA Brain 3.0 Intended for the spatial positioning and orientation Recalled by Zimmer Biomet, Inc. Due to Insufficient amount of washers in the Telescopic Arm,...

Date: May 27, 2016
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

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

Quantity: 3 units

Why Was This Recalled?

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Where Was This Sold?

This product was distributed to 1 state: DC

Affected (1 state)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