LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannul...

FDA Device Recall #Z-0421-2023 — Class II — August 3, 2022

Recall Summary

Recall Number Z-0421-2023
Classification Class II — Moderate risk
Date Initiated August 3, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Integrity Implants Inc.
Location Palm Beach Gardens, FL
Product Type Devices
Quantity 50 screws

Product 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 for Recall

Potential for intraoperative screw head separation at weld location.

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Integrity Implants Inc.

Recall # Classification Product Date
Z-1008-2025 Class II Brand Name: N/A Product Name: Repeater Bone Ta... Dec 20, 2024
Z-0419-2023 Class II LineSider Spinal System 5.5/6.0mm, Non-mod Stan... Jan 27, 2022
Z-0420-2023 Class II LineSider Spinal System 5.5/6.0mm, Non-mod MIS ... Jan 27, 2022
Z-0418-2023 Class II LineSider Spinal System 5.5/6.0mm, Non-mod Stan... Jan 27, 2022
Z-0405-2019 Class II FlareHawk Interbody Fusion System (previously X... Feb 27, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.