Recall Z-1360-2012 ยท ITH Equipment, Traction, Powered
Spinetronics, LLC
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*.
| Date | Apr 2, 2012 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 1600 brochures |
| Distribution | Worldwide Distribution, including Nationwide (USA) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.