BEUDAMED
    FDA Enforcement Class II Terminated

    ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

    Recall: Z-1704-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1704-2018
    Event ID
    79818
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    April 16, 2018
    Classification Date
    May 7, 2018
    Termination Date
    April 2, 2019
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

    Reason

    There may be burrs on the extraction hole threads.

    Code Info

    Lot Number HD6516, GTIN Number 10603295042280

    Distribution

    The products were distributed to the following US states: FL, MO, and PA.

    Quantity

    1 unit