Z-1073-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- January 17, 2019
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
Product Description
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.
Reason for Recall
On-X Valve was mislabeled with the incorrect serial number.
Distribution Pattern
Worldwide Distribution - US Nationwide - Georgia and Germany.
Code Information
Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024