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Integrity Implants Recalls
6 recalls on record · November 14, 2018 to January 29, 2025 · Medical Devices
Recalls by year
18
22
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 29, 2025Medical DevicesFDA
Integrity Implants Inc. recalls Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr
Hazard: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
December 14, 2022Medical DevicesFDA
Integrity Implants Inc. recalls LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N
Hazard: Potential for intraoperative screw head separation at weld location.
December 14, 2022Medical DevicesFDA
Integrity Implants Inc. recalls LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system;
Hazard: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
December 14, 2022Medical DevicesFDA
Integrity Implants Inc. recalls LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw sys
Hazard: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
December 14, 2022Medical DevicesFDA
Integrity Implants Inc. recalls LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw
Hazard: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
November 14, 2018Medical DevicesFDA
Integrity Implants Inc. recalls FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product
Hazard: Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.