[pending] Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Pla
Pending LLM rewrite. Source: FDA_DEVICE Z-0145-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
The recalled product
- Product
- 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 mea
- Manufacturer
- Kico Knee Innovation Company
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version V2025.1.2
Distribution
Distributed nationwide across the United States.
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