HIGH

ARVIS Surgical Navigation Software Recalled Over Malalignment Risk

ARVIS recalled 21 units of its Shoulder Surgical Navigation Software on September 19, 2025. A complaint identified issues that may cause implant malalignment and decreased range of motion. Healthcare providers and patients must stop using the software immediately.

Quick Facts at a Glance

Recall Date
September 19, 2025
Hazard Level
HIGH
Brand
Kico Knee Innovation
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

Product Details

The recalled product is the ARVIS Shoulder Surgical Navigation Software, Model IN-27300, Version V2025.1.2. It received nationwide distribution across states including Indiana, Minnesota, and Florida.

The Hazard

The recall stems from a complaint regarding the AI surgical planning software. It may lead to implant malalignment and decreased range of motion during shoulder surgeries.

Reported Incidents

No specific incidents or injuries have been reported yet. The risk is classified as high due to the potential for surgical complications.

What to Do

Patients and healthcare providers should stop using the software immediately. For further instructions, contact Kico Knee Innovation Company or your healthcare provider.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0145-2026.

Key Facts

  • Recalled item: ARVIS Shoulder Surgical Navigation Software
  • Model: IN-27300, Version V2025.1.2
  • Quantity: 21 systems recalled
  • Distribution: 15 states including CA, FL, and IN
  • High risk of implant malalignment
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSurgical Navigation Software
Sold At
Multiple Retailers

Product Details

Model Numbers
Software Version V2025.1.2
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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