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Brand Name: ARVIS recallZ-0145-2026 · Kico Knee Innovation Company · initiated Sep 19, 2025

Class II Open, Classified All recalls posted in October 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Kico Knee Innovation Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

FDA root cause category: Software change control

What the company is doing

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.

Recall details

Recall number
Z-0145-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 19, 2025
Posted by the FDA
Oct 14, 2025
Recalling firm
Kico Knee Innovation Company
Quantity
21 systems
Product code
SBF
FDA submissions
K243950
Distribution
US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.

Product description

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.

Code information (models, lots, serial numbers)

Software Version V2025.1.2

Other devices under the same FDA submission

1 device cleared under K243950 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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