Recall
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Blue Ortho · 22 Sept 2019
- Status
- Recall terminated
- Why, in the FDA's words
- “The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).”
- Recall began
- 22 Sept 2019
- Company
- Blue Ortho
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K152764
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.