Events

Recall of Device Recall Navitrack System OS Knee Universal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthosoft, Inc. dba Zimmer CAS.

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
    75612
  • Event Risk Class
    Class 3
  • Event Number
    Z-2075-2017
  • Event Initiated Date
    2008-06-20
  • Event Date Posted
    2017-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154948
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Zimmer cas voluntarily conducted a retrospective recall of the navitrack system - os knee universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
  • Action
    This is a retrospective report of a correction taken on 20 June 2008. The two software issues were corrected in the new software version 2.2.1.3. There were 164 copies of the affected software, 5 of which were only temporary licenses. There were 152 of the 159 software copies that had a full license that were confirmed to have installed the updated instructions per the correction notice for a total percentage of 96%. All sales representatives were made aware of the software issues by written notice. Both software issues were corrected in a new revision of the software with no remaining effect. There have been no complaints since the correction was implemented. Recall notices were e-mailed to customers dated 06/20/2008.

Device

Device Recall Navitrack System OS Knee Universal
  • Model / Serial
    Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
  • Product Description
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
  • Manufacturer
    Orthosoft, Inc. dba Zimmer CAS

Manufacturer

Orthosoft, Inc. dba Zimmer CAS
  • Manufacturer Address
    Orthosoft, Inc. dba Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA