BEUDAMED
    FDA Enforcement Class II Ongoing

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    Recall: Z-1738-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1738-2025
    Event ID
    96651
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier S.A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 14, 2025
    Initiation Date
    April 10, 2025
    Classification Date
    May 8, 2025
    Address
    161 Rue Lavoisier, N/A, Montbonnot-Saint-Martin, N/A, N/A, France

    Description

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    Reason

    A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

    Code Info

    Software Version 4.2.1

    Distribution

    Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.

    Quantity

    438 users