BEUDAMED
    FDA Recall Open, Classified

    BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9

    Recall: Z-0148-2026 · Initiated September 9, 2025

    Recall

    Recall Number
    Z-0148-2026
    Event Number
    97605
    Firm
    BioPro, Inc.
    FEI Number
    1832656
    Product Code
    LPH
    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 (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9

    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