Z-2075-2017Class III

Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Name: Z-2075-2017 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2008-06-20
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2008-06-20 / Terminated / root cause: software

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument on 2008-06-20. FDA classified it as Class III and gives the reason as "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". 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-2075-2017
Classification: Class III
Status: Terminated
Initiated: 2008-06-20
Posted: 2017-05-12
Terminated: 2017-05-15
Recalling firm: Zimmer CAS
Product: Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 152
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 codes and lots: Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2075-2017	Class III	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code HAW

K060336Class IINavitrack System-Os Knee Universal, Model Pro-05002Orthosoft, Inc. / cleared 2006-04-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)