BEUDAMED
    FDA Recall Terminated

    SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.

    Recall: Z-0571-2013 · Initiated November 12, 2012

    Recall

    Recall Number
    Z-0571-2013
    Event Number
    63788
    Firm
    BioMotion Medical Systems, LLC
    FEI Number
    3009896513
    Product Code
    BXB
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 12, 2012
    Posted
    December 20, 2012
    Terminated
    November 5, 2013
    Address
    6619 North Scottsdale Rd., scottsdale, AZ, 85250

    Description

    SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.

    Reason

    BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix.

    Action

    BioMotion issued a field correction letter dated October 18, 2012 for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to all affected customers. The letter identified the product, problem, and actions to be taken. BioMotion is preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. Contact the firm at 772-405-7899 for questions concerning this letter.

    Distribution

    Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.

    Quantity

    28 units