BEUDAMED
    FDA Enforcement Class II Terminated

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    Recall: Z-1717-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1717-2015
    Event ID
    71058
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Back Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2015
    Initiation Date
    May 13, 2015
    Classification Date
    June 5, 2015
    Termination Date
    May 23, 2018
    Address
    89 Cabot Ct Ste F, N/A, Hauppauge, NY, 11788-3719, United States

    Description

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    Reason

    Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs

    Code Info

    Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038

    Distribution

    Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.

    Quantity

    36 units