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Recall Observatory FDA recall evidence

Device product

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

Z-1809-2013

March 06, 2013

Class II

Product summary

Firm
Advanced Orthogonal Equipment, Incorporated
Event
Event 65391
Status
Terminated
Classification
Class II
Quantity
54
Official record key
device-enforcement:Z-1809-2013

Official wording

Reason: Unapproved medical device

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unapproved medical device