Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Stereotaxic instrument Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Navitrack System - OS Knee Universal, Stereotaxic instrument
Brand
Orthosoft, Inc. dba Zimmer CAS
Lot Codes / Batch Numbers
Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, A.42
Products Sold
Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
Orthosoft, Inc. dba Zimmer CAS is recalling Navitrack System - OS Knee Universal, Stereotaxic instrument due to Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54. 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 software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
Recommended Action
Per FDA guidance
This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008.
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, NY, NC, OH, OR, PA, RI, TN, TX, VA, WA
Page updated: Jan 10, 2026