[Recalled] 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 naviga
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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 measurements to the sur |
|---|---|
| Brand / manufacturer | Kico Knee Innovation Company |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0145-2026 |
| Country of notice | Australia |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 September 2025 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
This Class II recall concerns device products distributed in Australia and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.