Device recall
Z-1687-2026: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-1687-2026 |
|---|---|
| Recall event | 98482 |
| Product | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc |
| Product code | LCJ |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161176 |
| FEI number | 1000118360 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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