BEUDAMED
    FDA Enforcement Class II Terminated

    LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.

    Recall: Z-0421-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0421-2023
    Event ID
    91071
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integrity Implants Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 14, 2022
    Initiation Date
    August 3, 2022
    Classification Date
    December 5, 2022
    Termination Date
    October 23, 2023
    Address
    354 Hiatt Drive, N/A, Palm Beach Gardens, FL, 33418, United States

    Description

    LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.

    Reason

    Potential for intraoperative screw head separation at weld location.

    Code Info

    Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067

    Distribution

    US distribution to California, Indiana, New York, Oklahoma, Washington DC

    Quantity

    50 screws