Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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.
Why it was recalled
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Software Version V2025.1.2
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.
Recall record
- Recalling firm
- Kico Knee Innovation Company
- Product type
- Devices
- Recall number
- Z-0145-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Origin
- Pymble
- Recall initiated
- 2025-09-19
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0145-2026 · Source: openFDA enforcement.