Recall
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Globus Medical, Inc. · 7 Dec 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.”
- Recall began
- 7 Dec 2023
- Company
- Globus Medical, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K211616
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.