BEUDAMED
    FDA Enforcement Class II Terminated

    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

    Recall: Z-1809-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1809-2013
    Event ID
    65391
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Orthogonal Equipment, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    July 25, 2013
    Termination Date
    November 25, 2019
    Address
    2201 62nd Ave N, N/A, Saint Petersburg, FL, 33702-5660, United States

    Description

    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

    Reason

    Unapproved medical device

    Code Info

    Serial numbers: 001, 002, 008, 007, 006, 0010, 009, 011, 016, 015, 014, 023, 017, 018, 019, 020, 021, 024, 025, 022, 027, 026, 028, 029, 030, 031, 032, 033, 034, 035, 036, 038, 039, 037, 041, 042, 040, 043, 044, 045, 046, 048, 049, 050, 052, 053, 055, 056, 060, 058, 059, and 061

    Distribution

    Nationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA.

    Quantity

    54