BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1575-2014 · Initiated April 11, 2014

    Recall

    Recall Number
    Z-1575-2014
    Event Number
    68015
    Firm
    Blue Belt Technologies MN
    FEI Number
    3010266064
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 11, 2014
    Posted
    May 9, 2014
    Terminated
    June 10, 2014
    Address
    2905 Northwest Blvd, Ste 40, Plymouth, MN, 55441-2673

    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.

    Action

    Beginning April 3, 2014 consignees were hand delivered a Blue Belt Technologies, Inc. "Urgent Medical Device Recall" letter. The letter was addressed to Safety Officer / Regulatory Compliance Officer. The letter included the Description of the Issue, Description of Safety Concerns, Affected Product, Action to be taken by user, Transmission of this field safety notice and Contacts at Blue Belt Technologies. For questions in the USA contact Customer Support Blue Belt Technologies 2900 Northwest Blvd, Suite 40, Plymouth, MN 55441, USA, 1-763-452-4922 (Direct) [email protected]. In the European Union, Ross Lethbridge, European Product Manager, Blue Belt Technologies, Office number 207, 3000 Aviator Way. Manchester Business Park, Manchester, UK M22 5TG, Mobile: +44 7787 415069, [email protected].

    Distribution

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

    Quantity

    11