BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

    Recall: Z-0846-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0846-2025
    Event ID
    96030
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier S.A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    December 18, 2024
    Classification Date
    January 10, 2025
    Address
    161 Rue Lavoisier, Montbonnot-Saint-Martin, N/A, France

    Description

    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

    Reason

    The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

    Code Info

    UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979

    Distribution

    US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada

    Quantity

    24 units