BEUDAMED
    FDA Enforcement Class II Ongoing

    Z1 Femoral Hip System, Product Number 611777612

    Recall: Z-1329-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1329-2025
    Event ID
    96348
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2025
    Initiation Date
    February 12, 2025
    Classification Date
    March 13, 2025
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Z1 Femoral Hip System, Product Number 611777612

    Reason

    There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

    Code Info

    UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277

    Distribution

    US Nationwide distribution.

    Quantity

    35 units