Class II — Potential Health Hazard

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

MAZOR X robotic guidance system Recalled by Mazor Robotics Ltd Due to Software update

Date: September 5, 2023
Company: Mazor Robotics Ltd
Status: Ongoing
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 Mazor Robotics Ltd directly.

Affected Products

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Quantity: 324 devices

Why Was This Recalled?

Software update

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mazor Robotics Ltd

Mazor Robotics Ltd has 5 total recalls tracked by RecallDetector.

Related Recalls

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