Recall
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to…
Intellijoint Surgical, Inc. · 11 Feb 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.”
- Recall began
- 11 Feb 2020
- Company
- Intellijoint Surgical, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K191507
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.