BEUDAMED
    FDA Enforcement Class I Terminated

    PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

    Recall: Z-2743-2015 · Reported October 7, 2015

    Enforcement

    Recall Number
    Z-2743-2015
    Event ID
    71925
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2015
    Initiation Date
    August 4, 2015
    Classification Date
    September 28, 2015
    Termination Date
    August 17, 2018
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    Description

    PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

    Reason

    Unexpected rate of postoperative fractures resulting in the need for revision surgery.

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.

    Quantity

    10,489 units