BEUDAMED
    FDA Enforcement Class II Ongoing

    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

    Recall: Z-1038-2025 · Reported February 5, 2025

    Enforcement

    Recall Number
    Z-1038-2025
    Event ID
    96090
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2025
    Initiation Date
    January 6, 2025
    Classification Date
    January 28, 2025
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

    Reason

    It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.

    Code Info

    UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.

    Quantity

    155 units