Recall Z-1809-2013— Advanced Orthogonal Equipment, Incorporated

Name: FDA recall Z-1809-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class II · Terminated

Class II FDA medical device recall by Advanced Orthogonal Equipment, Incorporated, initiated 2013-03-06, terminated 2019-11-25. It names one FDA 510(k) clearance: K946258. Product: 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.

Recalling firm: Advanced Orthogonal Equipment, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Terminated: 2019-11-25
Firm location: Saint Petersburg, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K946258 — MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENTSpinalight, Inc.·cleared 1995-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Unapproved medical device

Data sourced from openFDA. This site is unofficial and independent of the FDA.