Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic...
FDA Device Recall #Z-1649-2022 - Class II, December 28, 2020
Recall Summary
| Recall Number | Z-1649-2022 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 28, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | New Standard Device Inc |
| Location | San Antonio, TX |
| Product Type | Devices |
| Quantity | 410 total devices |
Product Description
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Reason for Recall
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Distribution Pattern
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Lot / Code Information
Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
Other Recalls from New Standard Device Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1236-2022 | Class II | 1.8mm Truss Wire, REF: 900217, a Component of M... | Jun 8, 2020 |
| Z-1280-2022 | Class II | Metalogix Slotted 90 Tubular Wrench x 10mm REF ... | Aug 14, 2019 |
| Z-1824-2023 | Class II | 'n'-Hole Post which is a component of the Revol... | Jul 23, 2019 |
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.