Device recall
Z-2454-2019: Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate…
FDA device recall · Class I · Allergan PLC
Key facts
| Recall number (Z-number) | Z-2454-2019 |
|---|---|
| Recall event | 83500 |
| Product | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167… |
| Product code | FTR |
| Recalling firm | Allergan PLC |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P020056 |
| FEI number | 2011068 |
At a glance
- None 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