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Terminated

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

FDA Recall Z-1809-2013 · Posted 2013-07-25

Recalling FirmAdvanced Orthogonal Equipment, Incorporated
Recall StatusTerminated
Product CodeLXM
Date Initiated2013-03-06
Date Terminated2019-11-25
Product Quantity54

Reason for Recall

Unapproved medical device

Firm 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].

Root Cause

No Marketing Application

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K946258MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENTSpinalight, Inc. · 1995-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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