Recall Z-2588-2016— MicroPort Orthopedics Inc.

Name: FDA recall Z-2588-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-30

Class II · Terminated

Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2016-06-30, terminated 2017-01-21. It names one FDA 510(k) clearance: K003016. Product: 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.. Reason: Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck)..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Terminated: 2017-01-21
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K003016 — PRO-FEMUR RWrightmedicaltechnologyinc·cleared 2000-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.