BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

    Recall: Z-1651-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1651-2025
    Event ID
    96494
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 30, 2025
    Initiation Date
    March 3, 2025
    Classification Date
    April 22, 2025
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    Description

    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

    Reason

    A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

    Code Info

    GTIN 00846832015054, Batch Number CC0421265

    Distribution

    OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany

    Quantity

    5 units