Device recall
Z-1136-2013: EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories…
FDA device recall · Class II · Endogastric Solutions Inc
Key facts
| Recall number (Z-number) | Z-1136-2013 |
|---|---|
| Recall event | 64395 |
| Product | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis |
| Product code | ODE |
| Recalling firm | Endogastric Solutions Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2013 |
| 510(k) numbers | K092400 |
| FEI number | 3005473391 |
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