Recall Z-1136-2013 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Endogastric Solutions Inc
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
| Date | Apr 17, 2013 (initiated Feb 4, 2013) |
| Status | Terminated |
| Reason | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-92 |
| Quantity | 190 |
| Distribution | Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 Endogastric Solutions, Inc., Nov 6, 2009 |