PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to b...
FDA Device Recall #Z-0544-2014 — Class II — October 18, 2013
Recall Summary
| Recall Number | Z-0544-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SpineFrontier, Inc. |
| Location | Beverly, MA |
| Product Type | Devices |
| Quantity | 35 Devices |
Product Description
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Reason for Recall
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Distribution Pattern
US Distribution to VA and TX.
Lot / Code Information
Lot/Serial Numbers: 357305-000
Other Recalls from SpineFrontier, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-0576-2014 | Class II | Indus Invue Screws: IM71013-XX: Indus Screw04.0... | Nov 20, 2013 |
| Z-0554-2014 | Class II | PedFuse Reset Screw Inserters; PedFuse Screw In... | 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.