BEUDAMED
    FDA Recall Terminated

    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

    Recall: Z-0395-2022 · Initiated October 8, 2021

    Recall

    Recall Number
    Z-0395-2022
    Event Number
    88906
    Firm
    Civco Medical Instruments Co. Inc.
    FEI Number
    1937223
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 8, 2021
    Terminated
    September 30, 2024
    Address
    102 1st St S, Kalona, IA, 52247-9589

    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.

    Action

    The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units.

    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)