Recall
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Exactech, Inc. · 11 July 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Vix Bit may fracture during use.”
- Recall began
- 11 July 2017
- Company
- Exactech, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K162567
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.