BEUDAMED
    FDA Enforcement Class II Ongoing

    1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012

    Recall: Z-0063-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0063-2025
    Event ID
    95342
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    September 5, 2024
    Classification Date
    October 11, 2024
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012

    Reason

    May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.

    Code Info

    GTIN: 04546540362346 Lot number: 22329017

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Columbia.

    Quantity

    307 units