FDA Recall
Terminated
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Recall: Z-1809-2013
·
Initiated March 6, 2013
Recall
- Recall Number
- Z-1809-2013
- Event Number
- 65391
- Firm
- Advanced Orthogonal Equipment, Incorporated
- FEI Number
- 3006315109
- Product Code
- LXM
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- March 6, 2013
- Posted
- July 25, 2013
- Terminated
- November 25, 2019
- Address
- 2201 62nd Ave N, Saint Petersburg, FL, 33702-5660
Description
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Reason
Unapproved medical device
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].
Distribution
Nationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA.
Quantity
54