BEUDAMED
    FDA Enforcement Class II Terminated

    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

    Recall: Z-0395-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0395-2022
    Event ID
    88906
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Civco Medical Instruments Co. Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 29, 2021
    Initiation Date
    October 8, 2021
    Classification Date
    December 20, 2021
    Termination Date
    September 30, 2024
    Address
    102 1st St S, N/A, Kalona, IA, 52247-9589, United States

    Description

    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

    Reason

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

    Code Info

    Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

    Quantity

    52 boxes (5 units/box)