Recall Z-0145-2026 · SBF Orthopedic Augmented Reality
Kico Knee Innovation Company
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 Shoulde
| Date | Oct 14, 2025 (initiated Sep 19, 2025) |
| Status | Open, Classified |
| Reason | Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 21 systems |
| Distribution | US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243950 | ARVIS® Shoulder Kico Knee Innovation Company Pty, Ltd., Jan 13, 2025 |