Company: Mazor Robotics Ltd
Date of Enforcement Report: 9/16/2024
Class II
PRODUCT
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Recall Number:
Z-3156-2024
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Mazor Robotics Ltd
VOLUME OF PRODUCT IN COMMERCE:
94 devices
DISTRIBUTION:
US Nationwide distribution in PR.
