Kico Knee Innovation recalls 21 ARVIS Shoulder systems nationwide after reports that AI planning software may cause implant malalignment or reduced range of motion. The recall covers software version V2025.1.2 used with IN-27300 hardware. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
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
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ARVIS Shoulder is a computer-guided navigation system intended for intraoperative guidance in shoulder arthroplasty.
Artificial intelligence-driven planning may misalign implants or limit range of motion, impacting outcomes.
This recall is not part of a broader industry pattern.
High-level risk to surgical outcomes and potential need for revision procedures
Refer to FDA recall Z-0145-2026 and manufacturer communications
Remediation and refunds subject to manufacturer's process; typical timeframe similar orders 4-8 weeks
Maintain recall notice, correspondence, and patient outcomes data
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.
No detailed incident counts beyond the hazard description are provided in the source. The FDA notice lists the hazard as high.
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