BEUDAMED
    FDA Enforcement Class II Ongoing

    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

    Recall: Z-1620-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1620-2024
    Event ID
    94306
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 1, 2024
    Initiation Date
    February 28, 2024
    Classification Date
    April 23, 2024
    Address
    5770 Armada Dr, N/A, Carlsbad, CA, 92008-4608, United States

    Description

    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

    Reason

    Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

    Code Info

    REF/UDI-DI/Lots: MX1-001010/10889981298647/ AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F. AMRDXMIS/10889981303297/ AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005

    Distribution

    US: CA, FL, CO, TX

    Quantity

    444 Screw Heads