Device recall
Z-2957-2026: Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM…
FDA device recall · Class II · Kico Knee Innovation Company
Key facts
| Recall number (Z-number) | Z-2957-2026 |
|---|---|
| Recall event | 99372 |
| Product | Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled… |
| Product code | SBF |
| Recalling firm | Kico Knee Innovation Company |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K243950, K243980 |
| 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