BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1738-2025 · Initiated April 10, 2025

    Recall

    Recall Number
    Z-1738-2025
    Event Number
    96651
    Firm
    Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France
    FEI Number
    3000931034
    Product Code
    PHX
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    April 10, 2025
    Posted
    May 8, 2025

    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.

    Action

    On April 10, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed that an Online Management System (OMS) software patch was released to address the bug on March 25, 2025. The issue can no longer occur with the introduction of this patch. No actions are required on the customer's part to implement the patch. Version 4.2.2 is currently in development and is scheduled for release by end of Quarter 2, 2025. This patch will implement a permanent fix for the issue. Customers will be prompted to complete this update within the Blueprint Software when it is available.

    Distribution

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

    Quantity

    438 users