BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2588-2016 · Initiated June 30, 2016

    Recall

    Recall Number
    Z-2588-2016
    Event Number
    74752
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    LWJ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 30, 2016
    Posted
    August 18, 2016
    Terminated
    January 21, 2017
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    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

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

    Action

    The firm initiated their recall by email on 06/30/2016.

    Distribution

    Belgium, Italy, Spain, and Poland

    Quantity

    14 units