Device recall
Z-2463-2019: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles…
FDA device recall · Class I · Allergan PLC
Key facts
| Recall number (Z-number) | Z-2463-2019 |
|---|---|
| Recall event | 83500 |
| Product | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction |
| Product code | FTR |
| Recalling firm | Allergan PLC |
| Recall class | Class I |
| Status | Open, Classified |
| 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