BEUDAMED
    FDA Recall 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*.

    Recall: Z-1360-2012 · Initiated August 11, 2011

    Recall

    Recall Number
    Z-1360-2012
    Event Number
    61234
    Firm
    Spinetronics, LLC
    FEI Number
    3006746551
    Product Code
    ITH
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 11, 2011
    Posted
    April 2, 2012
    Terminated
    April 20, 2012
    Address
    10251 W Sample Rd, Coral Springs, FL, 33065-3928

    Description

    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*.

    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.

    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.

    Distribution

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

    Quantity

    1600 brochures