Medical Device Field Correction – August 2014.
A Filed correction is being conducted for Motion Concepts TRx Vertical Positioner system manufactured between June 2011 and May 2014. Motion Concepts has identified through on going testing and as a part of our ongoing evaluation of product return that there is possibility of knee support failure occurring through fatigue of two attachment bolts in our Vertical Positioning System.
Motion Concepts has determined that if the knee support assembly is mounted in such a way as to allow rocking, then hardware fatigue may occur. Rocking motion may be as a result of improperly tightened hardware after client fitting adjustment is completed. If hardware failure does occur, the knee block assembly shall no longer perform its support function possibly causing tissue and/or joint injury. Motion Concepts has received one injury reported associated with this issue. Motion Concepts is initiating this recall notice to ensure that proper information is provided to those who need it and so that any corrective action required is performed to mitigate any possible risk.
Motion Concepts is requesting that all consignees that have purchased a Motion Concepts TRx Vertical Positioner system in between June 2011 - May 2014 to make arrangements for replacement of the knee support mount at no cost. All Consignees have been notified regarding this correction through mail. If for some reason you currently do not have a provider, contact Motion Concepts as shown below so that we can assist you in getting your device corrected.
If you have any further questions related to this, please contact us
at 905-695-0134 or Quality@motionconcepts.com.