Recall
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Mako Surgical Corporation · 7 June 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.”
- Recall began
- 7 June 2017
- Company
- Mako Surgical Corporation
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K112507
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.