BEUDAMED
    FDA Enforcement Class II Terminated

    Certain Implant EP Twist Lock TM Coping Dental implants

    Recall: Z-2484-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2484-2016
    Event ID
    73184
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    August 16, 2016
    Termination Date
    July 26, 2019
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    Certain Implant EP Twist Lock TM Coping Dental implants

    Reason

    Pouches may not have been sealed during packing.

    Code Info

    Item: IWIT67

    Distribution

    Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

    Quantity

    1, 648,273 devices (all products subject to this recall)