PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis...
FDA Device Recall #Z-2942-2020 — Class I — July 31, 2020
Recall Summary
| Recall Number | Z-2942-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | July 31, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MicroPort Orthopedics Inc. |
| Location | Arlington, TN |
| Product Type | Devices |
| Quantity | 556 units |
Product Description
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Reason for Recall
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
Distribution Pattern
worldwide, except China and Japan
Lot / Code Information
All lots/serial numbers
Other Recalls from MicroPort Orthopedics Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1133-2026 | Class II | Brand Name: MicroPort Product Name: HIPTURN FE... | Dec 19, 2025 |
| Z-0699-2025 | Class II | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZ... | Oct 29, 2024 |
| Z-2244-2024 | Class II | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-p... | May 3, 2024 |
| Z-0276-2023 | Class II | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETP... | Oct 28, 2022 |
| Z-0275-2023 | Class II | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ET... | Oct 28, 2022 |
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.