Z-1360-2012

Removal of Literature/Brochures for Antalgic-Trak. "What is Antalgic-Trak?Articulating Non-Surgical...

Name: Z-1360-2012 Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical...
Creator: Spinetronics, LLC
Published: 2011-08-11
License: https://open.fda.gov/license/

Spinetronics, LLC / initiated 2011-08-11 / Terminated / root cause: labeling and UDI

FDA source

Spinetronics, LLC began a recall of Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By... on 2011-08-11. The reason FDA records is "On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1360-2012
Status: Terminated
Initiated: 2011-08-11
Posted: 2012-04-02
Terminated: 2012-04-20
Recalling firm: Spinetronics, LLC
Product: Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By Spinetronics***Note: "Decompression" as used herein refers to unloading due to distraction and positioning.***Antalgic-Trak is an improved form of non-surgical spinal decompression*.
Product code: ITH Equipment, Traction, Powered
Reason for recall: On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification in the intended use of the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Customer notification letters were mailed by certified mail via USPS. The medical user/customer was instructed to either return or destroy any remaining recalled product literature. Customers were asked to complete and return a response form noting the number of available brochures.
Quantity in commerce: 1600 brochures
Distribution: Worldwide Distribution, including Nationwide (USA) and the country of Canada.
Product codes and lots: NA

Product code ITH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)