Device recall
Z-0598-2020: XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439…
FDA device recall · Class II · Allergan PLC
Key facts
| Recall number (Z-number) | Z-0598-2020 |
|---|---|
| Recall event | 84220 |
| Product | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. |
| Product code | KYF |
| Recalling firm | Allergan PLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161457 |
| FEI number | 2011068 |
At a glance
- 1–9 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