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. Model Number REF TPL0059 Recalled by Mazor Robotics Ltd Due to Software anomalies which can result in two separate...

Date: July 17, 2024
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. Model Number REF TPL0059; stereotaxic orthopedic instrument

Quantity: 94 devices

Why Was This Recalled?

Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

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