Device recall
Z-0145-2026: Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300…
FDA device recall · Class II · Kico Knee Innovation Company
Key facts
| Recall number (Z-number) | Z-0145-2026 |
|---|---|
| Recall event | 97618 |
| 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… |
| Product code | SBF |
| Recalling firm | Kico Knee Innovation Company |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K243950 |
| FEI number | 3013552417 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database