Device recall
Z-2457-2019: Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable…
FDA device recall · Class I · Allergan PLC
Key facts
| Recall number (Z-number) | Z-2457-2019 |
|---|---|
| Recall event | 83500 |
| Product | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T… |
| Product code | LCJ |
| Recalling firm | Allergan PLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K102806, 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