PlainRecalls
FDA Devices Moderate Class II Ongoing

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Reported: October 18, 2023 Initiated: September 5, 2023 #Z-0101-2024

Product Description

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Reason for Recall

Software update

Details

Recalling Firm
Mazor Robotics Ltd
Units Affected
324 devices
Distribution
US Nationwide distribution.
Location
Caesarea, N/A

Frequently Asked Questions

What product was recalled?
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1. Recalled by Mazor Robotics Ltd. Units affected: 324 devices.
Why was this product recalled?
Software update
Which agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0101-2024.