Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is in...
FDA Device Recall #Z-2086-2013 — Class II — June 28, 2013
Recall Summary
| Recall Number | Z-2086-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 28, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alphatec Spine, Inc. |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 333 screws |
Product Description
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Reason for Recall
The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
Lot / Code Information
Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.
Other Recalls from Alphatec Spine, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1342-2026 | Class II | ATEC Lateral Navigation Disc Prep Instruments ... | Jan 2, 2026 |
| Z-1343-2026 | Class II | ATEC Lateral Navigation Disc Prep Instruments ... | Jan 2, 2026 |
| Z-1065-2025 | Class II | Calibrate CCX Interbody System for spinal fusio... | Dec 15, 2024 |
| Z-1182-2024 | Class II | IdentiTi ALIF Standalone Interbody System: Par... | Jan 26, 2024 |
| Z-2475-2023 | Class II | LIF AMP, Adjustable Awl, REF 117-165, Part of t... | Jul 7, 2023 |
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.