Kico Knee Innovation Company recalls Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300

Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.

On September 12, 2025, Kico Knee Innovation Company issued a recall notice to affected consignees. Kico asked consignees to take the following actions: 1. No actions are required by the surgeon users. 2. For the plans affected, Kico has quarantined these as they are not suitable for clinical use. 3. A long-term solution has been implemented to return the system to the specification of the most recently cleared device. We will contact surgeon users to login and re-plan their cases for upcoming surgeries.

• FDA enforcement recordOfficial FDA database entry for Z-0145-2026
• FDA 510(k) clearance · K243950The device's official FDA premarket clearance record
• FDA device classification · SBFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Kico Knee Innovation CompanySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.