MicroPort Orthopedics Inc. recalls PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for r…

Recall date

June 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2588-2016

FDA classification

Class II

Brand / firm

MicroPort Orthopedics Inc.

Sold / distributed

Belgium, Italy, Spain, and Poland

Why it was recalled

Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.