BEUDAMED
    FDA Recall 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 · Initiated January 17, 2019

    Recall

    Recall Number
    Z-1073-2019
    Event Number
    82044
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    LWQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 17, 2019
    Terminated
    June 9, 2020
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    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.

    Action

    The affected customer was initially notified via email on 01/16/2019. A follow up notification explaining the reason for recall was provided via email on about 01/24/2019. Instructions included to quarantine and return the affected device.

    Distribution

    Worldwide Distribution - US Nationwide - Georgia and Germany.

    Quantity

    2 devices