Orthosoft, Inc. dba Zimmer CAS Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument Recall
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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, 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. 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, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
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, MD, MN, MS, NJ, NY, NC, OR, PA, RI, SD, TN, TX, WA, WI
Page updated: Jan 10, 2026