Recall
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Mazor Robotics Ltd · 17 July 2024
- Status
- Recall open, classified
- Why, in the FDA's words
- “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.”
- Recall began
- 17 July 2024
- 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.