Mazor Robotics Ltd: Device Recall
Recall #Z-3156-2024 · 07/17/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3156-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mazor Robotics Ltd
- Status
- Ongoing
- Date Initiated
- 07/17/2024
- Location
- Caesarea, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94 devices
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.
Product Description
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Distribution Pattern
US Nationwide distribution in PR.
Other Recalls by Mazor Robotics Ltd
- Class II: Risk 12/10/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.