Recall Z-1809-2013 ยท LXM Manipulator, Plunger-Like Joint
Advanced Orthogonal Equipment, Incorporated
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
| Date | Jul 25, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | Unapproved medical device |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946258 | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT Spinalight, Inc., Nov 20, 1995 |