Kico Knee Innovation Recalls ARVIS Surgical Navigation System Due to Sensor Issue
Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.
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 classified as FDA Class II, and the hazard is a visual display issue (tilted image) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Kico Knee Innovation Company is recalling 78 units of the ARVIS Surgical Navigation System Gen 2 (Model IN-29200) due to an internal sensor issue. The affected software versions are ARVIS Hip and Knee Gap Balance Software v3.3.2 and ARVIS Shoulder Software v2.0.3. The system is a computer-controlled navigation device intended to provide intra-operative measurements to surgeons to aid in the selection and positioning of orthopedic implant components during procedures such as total knee arthroplasty and hip arthroplasty.
The recall is being conducted because the image displayed with the eyepiece may appear tilted relative to the eyepiece housing. This defect is attributed to an internal sensor issue. The recall covers 78 devices distributed to various medical distributors across the United States and Puerto Rico, including locations in Virginia, Texas, Wisconsin, Iowa, Illinois, Indiana, Kentucky, South Carolina, Colorado, Rhode Island, New York, Nebraska, California, Kansas, Alabama, Florida, Arizona, Hawaii, and Washington.
The source text does not specify a corrective action or instructions for consumers or healthcare providers. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system…
- Manufacturer
- Kico Knee Innovation Company
- Affected units
- 78
Distribution
Distributed in 1 state:
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