BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1073-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1073-2019
    Event ID
    82044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CryoLife, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2019
    Initiation Date
    January 17, 2019
    Classification Date
    March 28, 2019
    Termination Date
    June 9, 2020
    Address
    1655 Roberts Blvd Nw, N/A, Kennesaw, GA, 30144-3632, United States

    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

    On-X Valve was mislabeled with the incorrect serial number.

    Code Info

    Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024

    Distribution

    Worldwide Distribution - US Nationwide - Georgia and Germany.

    Quantity

    2 devices