MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device (fractures of hip prosthesis components) with reported device failures, which aligns with the rubric criteria for 'Severe' (structural defect or significant injury/property-damage reports).
Plain-English summary
MicroPort Orthopedics Inc. is recalling the PROFEMUR Neck Long Titanium hip prosthesis components, including catalog numbers PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, and PHA01264. The recall covers 123,284 units distributed worldwide, excluding China and Japan.
The recall is being conducted because of reports of fractures in the long and extra-long Titanium modular femoral neck components after they were implanted in patients. The company reports that globally, there were 680 fractures among 123,840 sales from 2002 to 2019, resulting in a cumulative fracture rate of 0.55%. In the United States, there were 349 fractures among 15,786 sales during the same period, representing a cumulative rate of 2.21%. The average time to device fracture after implantation is 5.4 years.
Patients who have had these specific hip prosthesis components implanted should contact their healthcare provider to discuss the recall and potential next steps.
The recalled product
- Product
- PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 123,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots/serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · MicroPort Orthopedics Inc.
See all →- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- ModerateFemoral Knee Prosthesis Components May Have Incorrect Packaging
FDA (Devices) · 2024-12-25
- HighMicroPort Knee Implant Recall: Wrong Size Component in Packaging
FDA (Devices) · 2024-07-10
- HighMicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging
FDA (Devices) · 2023-02-22
- HighEVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
FDA (Devices) · 2023-02-22
Same hazard · device fracture
See all →- HighSurgify Halo surgical burr recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- HighVASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
FDA (Devices) · 2025-04-30
- HighStryker ACM Bone Cement Mixer Nozzle May Break During Surgery
FDA (Devices) · 2023-09-27