BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    Recall: Z-1537-2025 · Reported April 16, 2025

    Enforcement

    Recall Number
    Z-1537-2025
    Event ID
    96437
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier S.A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 16, 2025
    Initiation Date
    March 5, 2025
    Classification Date
    April 8, 2025
    Address
    161 Rue Lavoisier, N/A, Montbonnot-Saint-Martin, N/A, N/A, France

    Description

    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    Reason

    Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

    Code Info

    All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022957

    Distribution

    US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

    Quantity

    17 units