Call us Toll Free at 1-866-242-0905 or
Click here to begin your FREE Case Review
A voluntary recall of the Blackstone Medical ICON Modular Fixation System from December 27, 2005 by device maker Blackstone Medical, Inc. was recently reclassified as Class I recall by the FDA on April 7th, 2006. Blackstone Medical ICON Modular Fixation System is a collection of surgical components used by surgeons to stabilize the spin during surgery and has come under fire recently for its potential for failure after implantation. This recall pertains to the components of system 54-9011.
The Food and Drug Administration and Blackstone Medical, Inc. recently notified healthcare professionals about a Class I recall involving the system of surgical components. The concern centers around the potential for the pedicle (or vertebra stem) screws to separate from the rods that run between spinal segments, known as screw heads. If this separation were to take place soon after the surgery, the spine could be unable to fuse properly, leading to debilitating pain and chronic disability.
The initial recall in December was issued after Blackstone Medical, Inc. received reports of a loosening of the construction in the system in the early postoperative period following surgery. Blackstone Medical, Inc. is requesting that past patients are notified by hospitals and surgeons after records are reviewed so that any potential danger can be averted.
The official FDA recall of the Blackstone Medical ICON Modular Fixation System is yet another example of corporate oversight potentially jeopardizing consumer safety. If you are one of the ICON users who have been left confused and frightened after the latest recall, you are not alone. Make sure you consult with your medical provider to make sure you are not at risk. If you or a loved one has suffered from adverse consequences caused by this device or another defective medical device, make sure to speak with a compassionate, experienced attorney today.
