Recall
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation, Inc. · 5 Dec 2019
- Status
- Recall open, classified
- Why, in the FDA's words
- “There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]”
- Recall began
- 5 Dec 2019
- Company
- Medtronic Navigation, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K182077
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.