BEUDAMED
    FDA Enforcement Class II Ongoing

    Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

    Recall: Z-1647-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1647-2025
    Event ID
    96493
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 30, 2025
    Initiation Date
    March 24, 2025
    Classification Date
    April 21, 2025
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

    Reason

    The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

    Code Info

    GTIN 00887868376344, All lots distributed with IFU 87-6204-051-99 Rev D or prior

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

    Quantity

    167 units