Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage:...
FDA Device Recall #Z-1989-2015 — Class II — June 9, 2015
Recall Summary
| Recall Number | Z-1989-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 9, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alliance Partners LLC |
| Location | San Antonio, TX |
| Product Type | Devices |
| Quantity | 21 units |
Product Description
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.
Reason for Recall
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
Distribution Pattern
US Nationwide Distribution in the states LA, TX, and PR.
Lot / Code Information
Lot numbers SM59161 and SM60278
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.