Z-0985-2009

Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical...

Name: Z-0985-2009 Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical...
Creator: Zimmer Inc.
Published: 2008-08-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-08-19 / Terminated / root cause: software

FDA source

Zimmer Inc. began a recall of Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument on 2008-08-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0985-2009
Status: Terminated
Initiated: 2008-08-19
Posted: 2009-03-02
Terminated: 2010-04-28
Recalling firm: Zimmer GmbH
Product: Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 75 (34 U.S. and 41 international)
Distribution: Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.
Product codes and lots: 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 code HAW

K071714Class IINavitrack System - Os Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. / cleared 2007-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)