Mazor Robotics Ltd: Device Recall

Recall #Z-1122-2026 · 12/10/2025

Class II: Risk

Recall Details

Recall Number: Z-1122-2026
Classification: Class II
Product Type: Device
Recalling Firm: Mazor Robotics Ltd
Status: Ongoing
Date Initiated: 12/10/2025
Location: Caesarea, Israel
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 549 systems

Reason for Recall

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

Product Description

Mazor X robotic guidance system REF: TPL0059

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.

Other Recalls by Mazor Robotics Ltd

Class II: Risk 07/17/2024

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.

View all recalls by Mazor Robotics Ltd →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.