Recall
Instructions For Use document of the GPS Trackers.
Blue Ortho · 10 Sept 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.”
- Recall began
- 10 Sept 2020
- Company
- Blue Ortho
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K193618
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.