Device recall
Z-0009-2019: ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX…
FDA device recall · Class I · Endologix
Key facts
| Recall number (Z-number) | Z-0009-2019 |
|---|---|
| Recall event | 80812 |
| Product | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA… |
| Product code | MIH |
| Recalling firm | Endologix |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 9, 2024 |
| PMA numbers | P040002, P040002S060, P040002S061 |
| FEI number | 3011063223 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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