Device recall
Z-0695-2019: PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The…
FDA device recall · Class II · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-0695-2019 |
|---|---|
| Recall event | 81773 |
| Product | PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue. |
| Product code | GDW |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2020 |
| 510(k) numbers | K030925 |
| FEI number | 1527736 |
At a glance
- 1–9 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