Zimmer CAS Recalls Navitrack System OS Knee Universal Software
Zimmer CAS is voluntarily recalling Navitrack System OS Knee Universal software versions due to software issues causing errors and discrepancies.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
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 a voluntary precautionary action for software errors and discrepancies with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer CAS is voluntarily conducting a retrospective recall of the Navitrack System - OS Knee Universal, a stereotaxic instrument. The recall involves software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54, and A.42. A total of 153 units are affected by this action.
The recall was initiated due to software issues that result in errors and discrepancies. The source text does not specify the nature of these errors or report any associated patient injuries or illnesses.
The affected units were distributed domestically in California, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, and Washington. International distribution included Canada, Australia, Austria, Brazil, China, the Czech Republic, France, Germany, Israel, Italy, Lebanon, Luxembourg, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United Kingdom. Users should contact Zimmer CAS for further instructions regarding the software issues.
The recalled product
- Product
- Navitrack System - OS Knee Universal, Stereotaxic instrument
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Hazard
- Affected units
- 153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number
- Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82
- A.42
Distribution
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