BEUDAMED
    FDA Enforcement Class II Terminated

    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

    Recall: Z-0703-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0703-2017
    Event ID
    75608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2016
    Initiation Date
    November 8, 2016
    Classification Date
    December 3, 2016
    Termination Date
    June 5, 2017
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

    Reason

    DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.

    Code Info

    LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294, GTIN: (01)10603295024484, Expiry: 31-Mar-2021

    Distribution

    US Distribution in the state of TN

    Quantity

    1