Device recall
Z-2780-2016: Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-2780-2016 |
|---|---|
| Recall event | 74899 |
| Product | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are… |
| Product code | LCJ |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2017 |
| 510(k) numbers | K150777 |
| 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