BEUDAMED
    FDA Enforcement Class II Terminated

    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

    Recall: Z-1703-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1703-2018
    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 LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

    Reason

    There may be burrs on the extraction hole threads.

    Code Info

    Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181

    Distribution

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

    Quantity

    2 units