Home / Recalls / Medical Devices
Mazor Robotics Ltd recalls Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Recalled September 25, 2024 · FDA recall Z-3156-2024 · Mazor Robotics
Hazard
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. · FDA Class II
Units
94 devices
Sold at
US Nationwide distribution in PR.
Description
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.
Product
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Manufacturer(s)
Mazor Robotics Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →