| Class 2 Device Recall Advanced Orthogonal Percussion Adjusting Instrument | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LXM
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