Device recall
Z-2104-2015: Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue…
FDA device recall · Class II · Allergan Inc
Key facts
| Recall number (Z-number) | Z-2104-2015 |
|---|---|
| Recall event | 71498 |
| Product | Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of… |
| Product code | LCJ |
| Recalling firm | Allergan Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2015 |
| 510(k) numbers | K865056 |
| FEI number | 2011068 |
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