Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Stereotaxic instrument Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
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
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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 11, 2026