United StatesThe affected product is the ARVIS Shoulder surgical navigation system (Brand: ARVIS; Model/Catalog IN-27300) running Arvis Surgical Planning Software Version V2025.1.2; 21 systems were distributed nationwide to hospitals/clinics in IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO and AL. A complaint identified an issue with the AI surgical planning software that may result in implant malalignment and/or decreased range of motion.
What's being recalled
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…
Recalling firm: Kico Knee Innovation Company, Pymble, Australia.
How to identify it
Software Version V2025.1.2
The hazard
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)