Kico Knee Innovation Company has recalled 21 units of its ARVIS Shoulder surgical planning software (Version V2025.1.2, Model IN-27300). A complaint identified a flaw in the system's AI surgical planning capabilities that can result in the incorrect alignment of orthopedic implants during surgery. This computer-controlled navigation system is designed to provide surgeons with precise measurements for positioning shoulder replacement components.
The software defect may lead to surgical implants being placed in an incorrect position or alignment. This could result in a decreased range of motion for the patient, joint instability, chronic pain, or the need for additional corrective surgeries.
Includes the Arvis Surgical Planning Software specifically used for shoulder arthroplasty navigation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.