PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, ...

FDA Device Recall #Z-2941-2020 — Class I — July 31, 2020

Recall Summary

Recall Number Z-2941-2020
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 123,284 units

Product Description

PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. 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.