Recall
Robotic Arm Interactive Orthopedic System (RIO)
Mako Surgical Corporation · 30 April 2014
- Status
- Recall terminated
- Why, in the FDA's words
- “Revision of the field manual”
- Recall began
- 30 April 2014
- Company
- Mako Surgical Corporation
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
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.