Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Brand
Orthosoft, Inc. dba Zimmer CAS
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
Orthosoft, Inc. dba Zimmer CAS is recalling Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument due to ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, GA, IL, IN, KS, MD, MN, MS, NJ, NY, NC, OR, PA, RI, SD, TN, TX, WA, WI
Page updated: Jan 10, 2026