Reported Oct 22, 2025 · Ongoing
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software…
Kico Knee Innovation Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kico Knee Innovation Company · Suite 3, Building 1, 20 Bridge St · Pymble · N/A
Is this the product you have?
- Brand NameARVIS
- Product NameARVIS"
- Shoulder Model/Catalog NumberIN-27300, Arvis Surgical
- Planning Software Software VersionV2025.1.2
- Product DescriptionIntended
- UseThe 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
- DescriptionARVIS 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
- Lot codes and dates
- Software Version V2025.1.2
- Amount recalled
- 21 systems
Where it was sold
Why it was recalled
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
This product could cause temporary or reversible health problems — stop using it.
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