Z-1809-2013Class II

Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in...

Name: Z-1809-2013 Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in...
Creator: Advanced Orthogonal Equipment, Incorporated
Published: 2013-03-06
License: https://open.fda.gov/license/

Spinalight Inc / initiated 2013-03-06 / Terminated

FDA source

Advanced Orthogonal Equipment, Incorporated began a recall of Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas... on 2013-03-06. FDA classified it as Class II and gives the reason as "Unapproved medical device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1809-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-07-25
Terminated: 2019-11-25
Recalling firm: Spinalight Inc
Product: Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Product code: LXM Manipulator, Plunger-Like Joint
Reason for recall: Unapproved medical device
FDA root cause: No Marketing Application
Action: The firm, Advanced Orthogonal Equipment, sent a "CORRECTION NOTICE" to its consignees/customers. The notice described the product, problem and actions to be taken. The customers were instructed that " none of these devices be used pending final clearance by FDA". Questions and concerns regarding this notice should be directed to the President of Advanced Orthogonal Equipment by phone at: 727-528-8700 or email: [email protected].
Quantity in commerce: 54
Distribution: Nationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-25

Product code LXM

K946258UnclassifiedModel 8000 Atlas C-1 Orthogonal Adjusting InstrumentSpinalight, Inc. / cleared 1995-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)