Recall
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Mako Surgical Corporation · 25 April 2019
- Status
- Recall terminated
- Why, in the FDA's words
- “The bearings of the saw attachments were ungreased.”
- Recall began
- 25 April 2019
- Company
- Mako Surgical Corporation
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K143752
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.