Recall
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to…
Mako Surgical Corporation · 7 Aug 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Software discrepancy of not showing all the EE constants, when the screen is filled.”
- Recall began
- 7 Aug 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.