Events

Recall of NavioPFSTM System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blue Belt Technologies MN.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68015
  • Event Risk Class
    Class 2
  • Event Number
    Z-1575-2014
  • Event Initiated Date
    2014-04-11
  • Event Date Posted
    2014-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126783
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic Sterotaxic Instrument - Product Code OLO
  • 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) lbrink@bluebelttech.com. 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, rlethbridge@bluebelttech.com.

Device

NavioPFSTM System
  • Model / Serial
    SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
  • Product Description
    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
  • Manufacturer
    Blue Belt Technologies MN

Manufacturer

Blue Belt Technologies MN
  • Manufacturer Address
    Blue Belt Technologies MN, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA