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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Orthogonal Percussion Adjusting Instrument

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  Class 2 Device Recall Advanced Orthogonal Percussion Adjusting Instrument see related information
Date Initiated by Firm March 06, 2013
Date Posted July 25, 2013
Recall Status1 Terminated 3 on November 25, 2019
Recall Number Z-1809-2013
Recall Event ID 65391
510(K)Number K946258  
Product Classification Manipulator, plunger-like joint - Product Code LXM
Product Advanced Orthogonal Percussion Adjusting Instrument

Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
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
Recalling Firm/
Manufacturer		 Advanced Orthogonal Equipment, Incorporated
2201 62nd Ave N
Saint Petersburg FL 33702-5660
For Additional Information Contact
727-528-8700
Manufacturer Reason
for Recall		 Unapproved medical device
FDA Determined
Cause 2		 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: Atlasortho@aol.com.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXM and Original Applicant = SPINALIGHT, INC.
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