The Recall Desk

Manufacturer

Integrity Implants Inc.

6 recalls in our database name Integrity Implants Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2025-01-29

Of the 6 recalls from Integrity Implants Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-1008-2025·2025-01-29

    Repeater Bone Tamp Recalled for Component Incompatibility in Spinal Fusion

    Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.

    Product
    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2023·2022-12-14

    LineSider Spinal System Screws Recalled for Potential Weld Separation

    Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2023·2022-12-14

    Spinal pedicle screws recalled for potential intraoperative screw head separation

    Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.

    Product
    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
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0420-2023·2022-12-14

    Spinal implant screws recalled for potential weld separation

    Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2023·2022-12-14

    Spinal Implant Screws Recalled Due to Potential Weld Failure

    LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2019·2018-11-14

    Integrity Implants Recalls FlareHawk Interbody Fusion System Instructions for Use

    Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.

    Product
    FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide