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U.S. Department of Health and Human Services

Class 2 Device Recall AntalgicTrak Literature

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  Class 2 Device Recall AntalgicTrak Literature see related information
Date Initiated by Firm August 11, 2011
Date Posted April 02, 2012
Recall Status1 Terminated 3 on April 20, 2012
Recall Number Z-1360-2012
Recall Event ID 61234
Product Classification Equipment, traction, powered - Product Code ITH
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*.
Code Information NA
Recalling Firm/
Manufacturer		 Spinetronics, LLC
10251 W Sample Rd
Coral Springs FL 33065-3928
For Additional Information Contact
954-649-6540
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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