BEUDAMED
    FDA Enforcement Class II Terminated

    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity

    Recall: Z-0151-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0151-2014
    Event ID
    66465
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    September 30, 2013
    Classification Date
    November 4, 2013
    Termination Date
    March 26, 2014
    Address
    4545 Creek Rd, N/A, Cincinnati, OH, 45242-2803, United States

    Description

    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity

    Reason

    During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

    Code Info

    The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.

    Distribution

    Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.

    Quantity

    Product Code: BD2XV - 1,248 units