Device product
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
Z-1073-2019
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 82044
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 devices
- Official record key
device-enforcement:Z-1073-2019
Official wording
Reason: On-X Valve was mislabeled with the incorrect serial number.
Code information: Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024
Distribution pattern: Worldwide Distribution - US Nationwide - Georgia and Germany.
Derived failure modes
-
Labeling or packaging
mislabeled