BEUDAMED
    FDA Enforcement Class II 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 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2588-2016
    Event ID
    74752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2016
    Initiation Date
    June 30, 2016
    Classification Date
    August 18, 2016
    Termination Date
    January 21, 2017
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    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).

    Code Info

    Lot number 1645222

    Distribution

    Belgium, Italy, Spain, and Poland

    Quantity

    14 units