BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-1136-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1136-2013
    Event ID
    64395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Endogastric Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    February 4, 2013
    Classification Date
    April 17, 2013
    Termination Date
    July 2, 2013
    Address
    8210 154th Ave NE, N/A, Redmond, WA, 98052-3877, United States

    Description

    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

    Reason

    EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

    Code Info

    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.

    Distribution

    Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,

    Quantity

    190