BEUDAMED
    FDA Enforcement Class II Terminated

    NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

    Recall: Z-0663-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0663-2018
    Event ID
    78960
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZIMMER ORTHOPEDIC MFG LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 28, 2018
    Initiation Date
    July 24, 2017
    Classification Date
    February 21, 2018
    Termination Date
    April 16, 2018
    Address
    Building No 2 East Park, Shannon Industrial Estate, Shannon, N/A, N/A, Ireland

    Description

    NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

    Reason

    There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

    Code Info

    Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.

    Quantity

    7 devices