BEUDAMED
    FDA Enforcement Class II Terminated

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    Recall: Z-1575-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1575-2014
    Event ID
    68015
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Blue Belt Technologies MN
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 21, 2014
    Initiation Date
    April 11, 2014
    Classification Date
    May 9, 2014
    Termination Date
    June 10, 2014
    Address
    2905 Northwest Blvd Ste 40, Plymouth, MN, 55441-2673, United States

    Description

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    Reason

    Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.

    Code Info

    SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247

    Distribution

    USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.

    Quantity

    11