BEUDAMED
    FDA Enforcement Class II Ongoing

    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

    Recall: Z-1433-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1433-2025
    Event ID
    96400
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2025
    Initiation Date
    February 27, 2025
    Classification Date
    March 24, 2025
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

    Reason

    The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

    Code Info

    UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792

    Distribution

    Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore.

    Quantity

    76 units