Recall
Mazor X robotic guidance system REF: TPL0059
Mazor Robotics Ltd · 10 Dec 2025
- Status
- Recall open, classified
- Why, in the FDA's words
- “Software errors that can result in incorrect surgical instrument positioning during spinal surgery.”
- Recall began
- 10 Dec 2025
- Company
- Mazor Robotics Ltd
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K230064
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.