Device recall
Z-2458-2019: McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for…
FDA device recall · Class I · Allergan PLC
Key facts
| Recall number (Z-number) | Z-2458-2019 |
|---|---|
| Recall event | 83500 |
| Product | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. |
| Product code | LCJ |
| Recalling firm | Allergan PLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K862203 |
| FEI number | 2011068 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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