BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3

    Recall: Z-0151-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0151-2026
    Event ID
    97605
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioPro, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 22, 2025
    Initiation Date
    September 9, 2025
    Classification Date
    October 14, 2025
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558, United States

    Description

    BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3

    Reason

    Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

    Code Info

    Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers

    Distribution

    US Domestic distribution to Texas and Michigan.

    Quantity

    147 total