Blackstone Medical ICON Modular Fixation System
The Food and Drug Administration recently issued a Class I recall for the Blackstone Medical ICON Modular Fixation System, coming on the heels of a voluntary recall issued by the device maker on December 27, 2005. This system is a group of components used in surgery for stabilizing the spine that has come under scrutiny for its potential failure after it has been implanted. This reclassification on April 7th, 2006 pertains to the various components of system 54-9011.
The FDA along with the company that manufacturers the device, Blackstone Medical, Inc. notified neurosurgeons, surgical service managers, hospital risk managers, and other healthcare professionals about the potential for separation between the system’s pedicle, or vertebra stem, screws and the screw heads, rods that run between spinal segments. The potential separation poses a particular danger in the early postoperative period following surgery, when it could keep the spine from fusing together properly and could lead to chronic pain and disability.
The original recall issued in December came after Blackstone Medical, Inc. received reports that the construction of the system was becoming loose in some patients during the period following surgery. The device maker is requesting that healthcare providers review their records of past patients so that these users can be notified to be checked for any potential dangers.
This latest FDA recall is another example of medical devices that are being discovered to have dangerous and potentially deadly consequences for their users. The Blackstone Medical ICON Modular Fixation System is not only jeopardizing consumer safety, but causing mass confusion and concern as well. If you are one of the many users who trusted the Medical ICON Modular Fixation System, don't suffer in silence any longer. After you consult with your medical provider about your specific medical situation, make sure to contact an understanding, knowledgeable, and experienced defective medical device attorney as soon as possible. Don't wait- you deserve answers today.
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