Mazor Robotics Ltd
FDA adverse event reports naming Mazor Robotics Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAZOR ROBOTICS LTD.
- Total reports
- 1,223
- Deaths
- 6
- Injuries
- 217
- Malfunctions
- 1,000
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
Recent recalls
- 2026-01-16Open, ClassifiedUnder Investigation by firm
Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- 2024-09-16Open, ClassifiedDevice Design
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
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.
- 2023-10-12Open, ClassifiedSoftware design
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Software update
- TerminatedDevice Design
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
- TerminatedOther
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction
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