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Integrity Implants Inc. FDA Recalls

5 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product DescrClass IIDec 20, 2024Due to incompatibility of bone tamp (Rev A) and bone funnels	Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).	Class IIDevices	Dec 20, 2024
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-NClass IIAug 3, 2022Potential for intraoperative screw head separation at weld l	Potential for intraoperative screw head separation at weld location.	Class IIDevices	Aug 3, 2022
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw sysClass IIJan 27, 2022Potential for weld separation of the Upper Tulip Head compon	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which wou	Class IIDevices	Jan 27, 2022
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screwClass IIJan 27, 2022Potential for weld separation of the Upper Tulip Head compon	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which wou	Class IIDevices	Jan 27, 2022
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Class IIJan 27, 2022Potential for weld separation of the Upper Tulip Head compon	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which wou	Class IIDevices	Jan 27, 2022

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