BEUDAMED
    FDA Enforcement Class II Ongoing

    Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))

    Recall: Z-1177-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1177-2025
    Event ID
    96179
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    XTANT Medical Holdings, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2025
    Initiation Date
    January 3, 2025
    Classification Date
    February 19, 2025
    Address
    664 Cruiser Ln, N/A, Belgrade, MT, 59714-9719, United States

    Description

    Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))

    Reason

    Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

    Code Info

    Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

    Quantity

    14 units