Recall Z-0571-2013
BioMotion Medical Systems, LLC · initiated November 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: serial numbers: 1001 through 1054
Reason for recall
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.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-0571-2013
- Initiated
- November 12, 2012
- Posted by FDA
- December 20, 2012
- Terminated
- November 5, 2013
- Product code
- BXB – Exerciser, Powered
- Quantity
- 28 units
- Distribution
- Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
- Recalling firm
- BioMotion Medical Systems, LLC, Scottsdale, AZ