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.
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
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
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 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.
No specific incidents or injuries have been reported yet. The risk is classified as high due to the potential for surgical complications.
Patients and healthcare providers should stop using the software immediately. For further instructions, contact Kico Knee Innovation Company or your healthcare provider.
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.
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