Device evidence

device-recall:cfres:116023

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

Official recall number

Z-1136-2013

Evidence summary

Product code: ODE
Recall status: Terminated
Event initiated: February 04, 2013
Root cause: Release of Material/Component prior to receiving test results
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1136-2013