Class II

Medical Device Recall: Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

Mazor Robotics Ltd · July 17, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution in PR.

States Affected

NATIONWIDE

Quantity Affected

94 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3156-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.