Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059

Recall date

December 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1122-2026

FDA classification

Class II

Brand / firm

Mazor Robotics Ltd

Sold / distributed

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, Slovak…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mazor X robotic guidance system REF: TPL0059