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 REF: TPL0059 Recalled by Mazor Robotics Ltd Due to Software errors that can result in incorrect surgical...

Date: December 10, 2025
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 REF: TPL0059

Quantity: 549 systems

Why Was This Recalled?

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

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