BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    Recall: Z-0981-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0981-2025
    Event ID
    95998
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    June 28, 2023
    Classification Date
    January 17, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    Reason

    There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

    Code Info

    GTIN 04546540467775, Lot Number 22174017

    Distribution

    Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

    Quantity

    464 units