Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash
Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is described as a voluntary retrospective recall for a software crash. The source text does not report any injuries, illnesses, or deaths, and the hazard is a technical malfunction rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer CAS is voluntarily recalling the Navitrack System - OS Knee Universal software, part number ORTHOsoft-UniTkr-2.3.2.6. This software application is intended to assist in the placement of total knee replacement components. The recall was initiated due to a calibration sequence crash.
The recall involves 105 units. The product was distributed in the United States, including Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington, and Wisconsin. It was also distributed internationally to Canada, Australia, Austria, Colombia, Denmark, France, Germany, Korea, New Zealand, Russia, South Africa, and Thailand.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled software. The agency classification for this recall is Class II.
The recalled product
- Product
- Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Hazard
- Affected units
- 105
Distribution
Related recalls
Same manufacturer · Orthosoft, Inc. dba Zimmer CAS
See all →- HighSurgical knee navigation implant recalled over sterilization failures
FDA (Devices) · 2022-03-09
- HighZimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability
FDA (Devices) · 2017-06-14
- ModerateZimmer CAS Recalls Navitrack System OS Knee Universal Software
FDA (Devices) · 2017-05-24
- ModerateZimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
FDA (Devices) · 2017-05-24
- ModerateZimmer CAS Recalls NDI P7 Position Sensors for Potential Malfunction
FDA (Devices) · 2017-05-17
Same hazard · software crash
See all →- HighFlow cytometers recalled over software that crashes during sample acquisition
FDA (Devices) · 2025-11-26
- HighSensis Vibe diagnostic systems software crash during event documentation
FDA (Devices) · 2024-07-31
- HighSensis Vibe Cardiac Imaging System Software May Crash During Documentation
FDA (Devices) · 2024-07-31
- HighSensis Vibe medical diagnostic system software crashes during documentation events
FDA (Devices) · 2024-07-31
- ModerateMedical device diagnostic software vulnerability causes potential application crashes
FDA (Devices) · 2024-07-31