FDA-Device2016-08-24Class II

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.

MicroPort Orthopedics Inc.
Hazard

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

Sold states
Belgium, Italy, Spain, and Poland
Affected count
14 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2588-2016

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