Device recall
Z-0945-2026: Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog…
FDA device recall · Class II · DSAART LLC
Key facts
| Recall number (Z-number) | Z-0945-2026 |
|---|---|
| Recall event | 97704 |
| Product | Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI… |
| Product code | MIB |
| Recalling firm | DSAART LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K021839 |
| 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