Recall
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Brainlab AG · 16 July 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “Incorrect manufacturer calibration”
- Recall began
- 16 July 2020
- Company
- Brainlab AG
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K183605
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.