Device recall
Z-0946-2026: Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers…
FDA device recall · Class II · DSAART LLC
Key facts
| Recall number (Z-number) | Z-0946-2026 |
|---|---|
| Recall event | 97704 |
| Product | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1… |
| Product code | FWP |
| Recalling firm | DSAART LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K021417 |
| FEI number | 3003897287 |
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