FDA-Device2024-09-25Class II
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Mazor Robotics Ltd
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.
Sold states
US Nationwide distribution in PR.
Affected count
94 devices
Manufactured in
North Industrial Park, 5, Shacham Street, Caesarea, Israel
Products
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3156-2024Don't want to check this manually?
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