BEUDAMED
    FDA Recall 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 · Initiated August 3, 2022

    Recall

    Recall Number
    Z-0421-2023
    Event Number
    91071
    Firm
    Integrity Implants Inc.
    FEI Number
    3012797630
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 3, 2022
    Posted
    December 5, 2022
    Terminated
    October 23, 2023
    Address
    354 Hiatt Drive, Palm Beach Gardens, FL, 33418

    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.

    Action

    Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form.

    Distribution

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

    Quantity

    50 screws