ARVIS Shoulder System (Kico) – surgical planning flaw (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Kico Knee Innovation Company
Lot Codes / Batch Numbers
Software Version V2025.1.2
Products Sold
Software Version V2025.1.2
Kico Knee Innovation Company is recalling Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Plann due to Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026