Reported Sep 30, 2020 · Terminated
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip…
MicroPort Orthopedics Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroPort Orthopedics Inc. · 5677 Airline Rd · Arlington, TN · 38002-9501
Is this the product you have?
- PROFEMUR Neck Long Titanium
- Catalog Numbers
PHA01204PHA01214PHA01224PHA01234PHA01244PHA01254PHA01264. Hip prosthesis component
- Lot codes and dates
- All lots/serial numbers
- Amount recalled
- 123,284 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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