Recall
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medtronic Sofamor Danek USA, Inc · 12 July 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “Incorrect Laser Marking - Solera Awl Tip Tap”
- Recall began
- 12 July 2023
- Company
- Medtronic Sofamor Danek USA, Inc
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K140454
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.