BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

    Recall: Z-0153-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0153-2026
    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 Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

    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 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 All lots, all serial numbers

    Distribution

    US Domestic distribution to Texas and Michigan.

    Quantity

    147 total