Mazor Robotics Ltd: Mazor X Robotic Guidance System Recalled for Necessary Software Update

What You Should Do

1. Identify if your facility uses the MAZOR X robotic guidance system, Model TPL0059, specifically checking for software versions 4.2.2 or 5.0.1.
2. Cross-reference your device serial number with the affected lists, which include GTIN 07290109180465 (e.g., 4000770717, 4001180118), GTIN 07290109181158 (e.g., 4001200218, 4001740219), GTIN 07290109183213 (e.g., 4001770219, 4004670322), and GTIN 07290115751376 (e.g., 4004680322, 4006750823).
3. Contact Mazor Robotics Ltd or your Medtronic representative to schedule the necessary software update if it has not already been performed.
4. If you are a patient who has undergone surgery involving this device and have concerns, contact your healthcare provider or surgeon for further instructions.
5. Contact Mazor Robotics Ltd directly at their Caesarea, Israel location or through their US-based distribution channels for technical support and potential remedy options.
6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

Affected Products