BEUDAMED
    FDA Enforcement Class II Terminated

    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.

    Recall: Z-2040-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-2040-2018
    Event ID
    79822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Torax Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    April 20, 2018
    Classification Date
    May 31, 2018
    Termination Date
    November 4, 2020
    Address
    4188 Lexington Ave N, N/A, Shoreview, MN, 55126-6106, United States

    Description

    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.

    Reason

    Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

    Code Info

    a. Product Code LX-12, Part No. 2684-12, GTIN 00855106005073; b. Product Code LX-13, Part No. 2684-13, GTIN 00855106005080; c. Product Code LX-14, Part No. 2684-14, GTIN 00855106005097; d. Product Code LX-15, Part No. 2684-15, GTIN 00855106005103; e. Product Code LX-16, Part No. 2684-16, GTIN 00855106005110; f. Product Code LX-17, Part No. 2684-17, GTIN 00855106005127; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557

    Distribution

    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.

    Quantity

    9,131 devices in total