Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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*.

FDA Recall Z-1360-2012 · Posted 2012-04-02

Recalling FirmSpinetronics, LLC
Recall StatusTerminated
Product CodeITH
Date Initiated2011-08-11
Date Terminated2012-04-20
Product Quantity1600 brochures

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.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution, including Nationwide (USA) and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑