Recall
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Mako Surgical Corporation · 22 Dec 2016
- Status
- Recall terminated
- Why, in the FDA's words
- “Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides”
- Recall began
- 22 Dec 2016
- 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.