Recall
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl · 23 July 2026
- Status
- Recall open, classified
- Why, in the FDA's words
- “Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.”
- Recall began
- 23 July 2026
- Company
- Medos International Sarl
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K233228
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.