Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
PROFEMUR Neck Long Titanium Recalled by MicroPort Orthopedics Inc. Due to MicroPort Orthopedics Inc. states that there have been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MicroPort Orthopedics Inc. directly.
Affected Products
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Quantity: 123,284 units
Why Was This Recalled?
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.
Where Was This Sold?
worldwide, except China and Japan
About MicroPort Orthopedics Inc.
MicroPort Orthopedics Inc. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report