Z-0145-2026Class II

Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning...

Name: Z-0145-2026 Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning...
Creator: Kico Knee Innovation Company
Published: 2025-09-19
License: https://open.fda.gov/license/

Kico Knee Innovation Company / initiated 2025-09-19 / Open, Classified / root cause: software

FDA source

Kico Knee Innovation Company began a recall of Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product... on 2025-09-19. FDA classified it as Class II and gives the reason as "Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0145-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-19
Posted: 2025-10-14
Recalling firm: Kico Knee Innovation Company
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 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.
Product code: SBF Orthopedic Augmented Reality
Reason for recall: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Software Version V2025.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0145-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0145-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14

Product code SBF

K243950Class IIARVIS® ShoulderKico Knee Innovation Company Pty, Ltd. / cleared 2025-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)