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Mazor Robotics Ltd FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Mazor X robotic guidance system REF: TPL0059Class IIDec 10, 2025Software errors that can result in incorrect surgical instru |
| Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrumentClass IIJul 17, 2024Software anomalies which can result in two separate issues: |
| MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1Class IISep 5, 2023Software update |