Device recall
Z-2455-2019: Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and…
FDA device recall · Class I · Allergan PLC
Key facts
| Recall number (Z-number) | Z-2455-2019 |
|---|---|
| Recall event | 83500 |
| Product | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14… |
| 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