BEUDAMED
    FDA Enforcement Class II Ongoing

    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    Recall: Z-1478-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1478-2024
    Event ID
    94163
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Navinetics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 10, 2024
    Initiation Date
    February 26, 2024
    Classification Date
    April 4, 2024
    Address
    206 S Broadway Ste 700, Rochester, MN, 55904, United States

    Description

    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    Reason

    Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.

    Code Info

    UDI/DI 10850023620276, Lot Number 331401724

    Distribution

    US Nationwide distribution in the states of FL, MN, CO.

    Quantity

    20 kits