Quick Facts at a Glance
- Recall Date
- September 19, 2025
- Hazard Level
- HIGH
- Brands
- Kico Knee Innovation, ARVIS
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Kico Knee Innovation, ARVIS
- Product type
- Surgical Navigation System
- Model numbers
- IN-27300, V2025.1.2
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 19, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Kico Knee Innovation Company or your healthcare provider for instructions. Notification method: E-Mail
About This Product
ARVIS Shoulder is a computer-guided navigation system intended for intraoperative guidance in shoulder arthroplasty.
Why This Is Dangerous
Artificial intelligence-driven planning may misalign implants or limit range of motion, impacting outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High-level risk to surgical outcomes and potential need for revision procedures
Practical Guidance
How to identify if yours is affected
- Verify software version V2025.1.2 and model IN-27300
- Check distributor and shipment records for the listed states
- Review internal hospital IT logs for AI-planning anomalies
Where to find product info
Refer to FDA recall Z-0145-2026 and manufacturer communications
What timeline to expect
Remediation and refunds subject to manufacturer's process; typical timeframe similar orders 4-8 weeks
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with CPSC if consumer exposure is evident
- Consider legal counsel for adverse events
How to prevent similar issues
- Verify software versions before surgeries
- Routinely audit AI-assisted planning outputs
- Maintain offline backups of preoperative plans
- Stay updated with manufacturer advisories
Documentation advice
Maintain recall notice, correspondence, and patient outcomes data
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Product Details
Brand: Kico Knee Innovation. Product: ARVIS Shoulder system. Model/Catalog: IN-27300. Software Version: V2025.1.2. Intended Use: Computer-controlled navigation to aid intraoperative measurements and implant positioning in shoulder arthroplasty. Distribution: US nationwide in IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL. Quantity: 21 systems.
Reported Incidents
No detailed incident counts beyond the hazard description are provided in the source. The FDA notice lists the hazard as high.
Key Facts
- Software version V2025.1.2
- US nationwide distribution in 15 states
- High hazard level
- Recall status ACTIVE
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