Recall
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Exactech, Inc. · 5 June 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.”
- Recall began
- 5 June 2023
- Company
- Exactech, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
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.