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 Surgical Device 2.5.8. It is intended to be used Recalled by Zimmer Biomet, Inc. Due to An undetected shift between the information displayed in...

Date: February 14, 2014
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 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

Quantity: 21 (4 US and 17 OUS)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: MI, OH, TX

Affected (3 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