FDA recall Z-0101-2024
Mazor Robotics Ltd · Class II · device
Product
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Reason for recall
Software update
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-09-05
- Report date
- 2023-10-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Caesarea, N/A, Israel
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0101-2024