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
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For Additional Information Contact |
954-649-6540
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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.
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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
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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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