Recall
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Mako Surgical Corporation · 8 Aug 2022
- Status
- Recall terminated
- Why, in the FDA's words
- “Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.”
- Recall began
- 8 Aug 2022
- Company
- Mako Surgical Corporation
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K121064
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.