Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14...
FDA Device Recall #Z-0777-2014 — Class II — September 24, 2013
Recall Summary
| Recall Number | Z-0777-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SpineFrontier, Inc. |
| Location | Beverly, MA |
| Product Type | Devices |
| Quantity | 23 devices in total |
Product Description
Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
Reason for Recall
Handles and heads may not be compatible.
Distribution Pattern
US Distribution: VA only.
Lot / Code Information
2572401, 2572402, 2572405, 05172, 2572403, 2572404
Other Recalls from SpineFrontier, Inc.
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|---|---|---|---|
| Z-1973-2019 | Class II | A-CIFT SoloFuse Fixed Angle Driver, Model Numbe... | Jun 13, 2019 |
| Z-1479-2015 | Class II | SpineFrontier MISquito Percutaneous Pedicle S... | Mar 5, 2015 |
| Z-0977-2015 | Class II | lnline Persuader- PedFuse Pedicle Screw System;... | Dec 19, 2014 |
| Z-0554-2014 | Class II | PedFuse Reset Screw Inserters; PedFuse Screw In... | Nov 20, 2013 |
| Z-0576-2014 | Class II | Indus Invue Screws: IM71013-XX: Indus Screw04.0... | Nov 20, 2013 |
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.