Recall Z-3156-2024— Mazor Robotics Ltd
Class II · Ongoing
Class II FDA medical device recall by Mazor Robotics Ltd, initiated 2024-07-17. It names one FDA 510(k) clearance: K230064. Product: Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument. 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
- Mazor Robotics Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-17
- Firm location
- Caesarea, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.