Zimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
Zimmer CAS is voluntarily recalling 152 units of the Navitrack System - OS Knee Universal due to software anomalies corrected in a new revision.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a software anomaly corrected by a revision, with no reported injuries or illnesses.
Plain-English summary
Zimmer CAS (Orthosoft, Inc.) is voluntarily conducting a retrospective recall of the Navitrack System - OS Knee Universal, an orthopedic stereotaxic instrument. The recall involves 152 units of the software application Orthosoft Universal TKR, specifically release version ORTHOsoft-UniTkr-2.2.0.82.
The recall was initiated due to software anomalies that have been corrected in a new revision, version 2.2.1.3. The affected products were distributed domestically in California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Minnesota, Mississippi, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Washington, and Wisconsin. International distribution included Germany, Spain, the Czech Republic, the Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, and the United Kingdom.
Healthcare facilities and users should contact Zimmer CAS for instructions on how to obtain the corrected software revision. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Hazard
- Affected units
- 152
Distribution
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