Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chi
FDA device recall Z-1809-2013 · posted 2013-07-25 · Terminated
Recall details
- Recalling firm
- Advanced Orthogonal Equipment, Incorporated
- Reason for recall
- Unapproved medical device
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- LXM
- Quantity affected
- 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.
- Date initiated
- 2013-03-06
- Date posted
- 2013-07-25
- Date terminated
- 2019-11-25
- Location
- Saint Petersburg, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (K946258) | Spinalight, Inc. | 1995-11-20 |