BEUDAMED
    FDA Enforcement Class II Ongoing

    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

    Recall: Z-1038-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1038-2026
    Event ID
    97996
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2026
    Initiation Date
    October 29, 2025
    Classification Date
    January 9, 2026
    Address
    5389 route de Strasbourg, Vancia, Rillieux La Pape, N/A, France

    Description

    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

    Reason

    Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

    Code Info

    Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677

    Distribution

    US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

    Quantity

    44 units