BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 9, 2025

    Recall

    Recall Number
    Z-0153-2026
    Event Number
    97605
    Firm
    BioPro, Inc.
    FEI Number
    1832656
    Product Code
    JDI
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    September 9, 2025
    Posted
    October 14, 2025
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558

    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.

    Action

    Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.

    Distribution

    US Domestic distribution to Texas and Michigan.

    Quantity

    147 total