Device recall
Z-0947-2026: Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number…
FDA device recall · Class II · DSAART LLC
Key facts
| Recall number (Z-number) | Z-0947-2026 |
|---|---|
| Recall event | 97704 |
| Product | Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026 |
| Product code | LZK |
| Recalling firm | DSAART LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K021419 |
| 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