Device recall
Z-2219-2019: IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following…
FDA device recall · Class II · Ideal Implant Incorporated
Key facts
| Recall number (Z-number) | Z-2219-2019 |
|---|---|
| Recall event | 83251 |
| Product | IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc. |
| Product code | FWM |
| Recalling firm | Ideal Implant Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2021 |
| PMA numbers | P120011 |
| FEI number | 3008342021 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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