BEUDAMED
    FDA Recall 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 · Initiated September 30, 2013

    Recall

    Recall Number
    Z-0151-2014
    Event Number
    66465
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    September 30, 2013
    Posted
    November 5, 2013
    Terminated
    March 26, 2014
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    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.

    Action

    Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt. The letter identified affected products, problem and actions to be taken. Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.

    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