Mazor Robotics Ltd recalls Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

Recall date

July 17, 2024

Source

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

Recall number

Z-3156-2024

FDA classification

Class II

Brand / firm

Mazor Robotics Ltd

Sold / distributed

US Nationwide distribution in PR.

Why it was 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.

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. Model Number REF TPL0059; stereotaxic orthopedic instrument