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U.S. Department of Health and Human Services

Class 2 Device Recall ARVIS

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 Class 2 Device Recall ARVISsee related information
Date Initiated by FirmSeptember 19, 2025
Date PostedOctober 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0145-2026
Recall Event ID 97618
510(K)NumberK243950 
Product Classification Orthopedic Augmented Reality - Product Code SBF
ProductBrand 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.
Code Information Software Version V2025.1.2
Recalling Firm/
Manufacturer		 Kico Knee Innovation Company
Suite 3, Building 1, 20 Bridge St
Pymble Australia
Manufacturer Reason
for Recall		Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
FDA Determined
Cause 2		Software change control
ActionOn 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 in Commerce21 systems
DistributionUS Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = SBF
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