Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-670...
FDA Device Recall #Z-0896-2013 — Class II — February 1, 2013
Recall Summary
| Recall Number | Z-0896-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 1, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Orthofix, Inc |
| Location | Lewisville, TX |
| Product Type | Devices |
| Quantity | 565 total (287 PN 52-6800 and 278 PN 52- 6700) |
Product Description
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Reason for Recall
There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Distribution Pattern
Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Lot / Code Information
Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
Other Recalls from Orthofix, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2116-2018 | Class II | Rival Reduce Kit Locking and Non-Locking Screw ... | Apr 6, 2018 |
| Z-2129-2018 | Class II | Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r... | Apr 6, 2018 |
| Z-2135-2018 | Class II | Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Ital... | Apr 6, 2018 |
| Z-2130-2018 | Class II | L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Ital... | Apr 6, 2018 |
| Z-2118-2018 | Class II | Rival Reduce Kit Plates, Sterile, Rx Only, ORTH... | Apr 6, 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.