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U.S. Department of Health and Human Services

Class 2 Device Recall SpineSix01/SpineSix02

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 Class 2 Recall
SpineSix01/SpineSix02
see related information
Date Posted December 20, 2012
Recall Status1 Terminated on November 05, 2013
Recall Number Z-0571-2013
Recall Event ID 63788
Product Classification Exerciser, Powered - Product Code BXB
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.
Code Information serial numbers: 1001 through 1054
Recalling Firm/
Manufacturer
BioMotion Medical Systems, LLC
6619 North Scottsdale Rd.
scottsdale, Arizona 85250
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Thomas W. Larkin
480-296-2041
Manufacturer 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 2
PREMARKET APPROVAL: No Marketing Application
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.
Quantity in Commerce 28 units
Distribution Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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