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 Recalled by Zimmer Biomet, Inc. Due to Potential for software to change the final tool...

Date: April 8, 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 Surgical Device 2.5.8

Quantity: 64 units

Why Was This Recalled?

Potential for software to change the final tool orientation for the command position without command.

Where Was This Sold?

This product was distributed to 16 states: AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, WA

Affected (16 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