MicroPort Orthopedics Inc.: Medical Device Recall in 2020 - (Recall #: Z-2941-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: July 31, 2020

Date Posted: September 30, 2020

Recall Number: Z-2941-2020

Event ID: 86153

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.

Status: Terminated

Product Quantity: 123,284 units

Code Information:

All lots/serial numbers

Distribution Pattern:

worldwide, except China and Japan

Voluntary or Mandated:

Voluntary: Firm initiated