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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscope Clip applier, Implantable Fastener and Accessories

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  Class 2 Device Recall Endoscope Clip applier, Implantable Fastener and Accessories see related information
Date Initiated by Firm February 04, 2013
Date Posted April 17, 2013
Recall Status1 Terminated 3 on July 02, 2013
Recall Number Z-1136-2013
Recall Event ID 64395
510(K)Number K092400  
Product Classification Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
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
Code Information Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
Recalling Firm/
Manufacturer		 Endogastric Solutions Inc
8210 154th Ave NE
Redmond WA 98052-3877
For Additional Information Contact Steve Hoffman
425-307-9200
Manufacturer Reason
for Recall		 EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
FDA Determined
Cause 2		 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 425-307-9200.
Quantity in Commerce 190
Distribution Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ODE and Original Applicant = ENDOGASTRIC SOLUTIONS, INC.
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