Z-2941-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- July 31, 2020
- Termination Date
- April 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
All lots/serial numbers