Events

Recall of Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0

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

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
    50746
  • Event Risk Class
    Class 2
  • Event Number
    Z-0985-2009
  • Event Initiated Date
    2008-08-19
  • Event Date Posted
    2009-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76911
  • 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 surgical stereotaxic instrument software - Product Code HAW
  • Reason
    Incorrect parameters: if the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for.
  • Action
    Zimmer notified consignees via letter dated 8/19/08, which advised them not to change the selected surgeon profile after the acquisition of landmarks has begun, and the issued will be fixed with the next software release.

Device

Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0
  • Model / Serial
    All units with software versions/distribution numbers Orthosoft-unicondylar 1.0.2.31, Orthosoft-unicondylar 1.0.1.28 and Orthosoft-unicondylar 1.0.0.0.111.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.
  • Product Description
    Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA