Class II — Kico Knee Innovation Company
| Recalling firm | Kico Knee Innovation Company |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. |
| 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 surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joi… |
| Quantity | 21 systems |
| Distribution | US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL. |
| Initiated | 2025-09-19 |
| Classified | 2025-10-14 |
| Recall number | Z-0145-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kico Knee Innovation Company (Z-0145-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97618/
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