Recall of Blackstone Medical's ICON Modular Fixation System

If you have had serious complications after spinal surgery where Blackstone Medical’s ICON Modular Fixation System was used, a lawyer at PritzkerOlsen, P.A., a nationally-recognized law firm, is available for a free consultation. You may reach us toll-free at 1-888-377-8900 or fill in our online consultation form. Senior partner Fred Pritzker has over 30 years of experience and focuses his practice on complex product liability cases. In recognition of his achievements, other lawyers have selected him for inclusion in the current edition of The Best Lawyers in America. He has written online information on defective medical product lawsuits.

Blackstone Medical’s ICON Modular Fixation System: Lawyer Fred Pritzker Provides Information on Recall
In April of 2006, the Food and Drug Administration (FDA) announced a recall of Blackstone Medical’s ICON Modular Fixation System. The ICON Modular Fixation System is used for spinal surgery. Specifically:

The ICON™ Modular Fixation System is a collection of components that allows the surgeon to assemble a construct including screws, connectors and rods. The construct is implanted in and near the patient's spine, and is intended to immobilize and stabilize spinal segments at the site of spine surgery. (FDA Recall Notifictation)

According to the recall notification, The construct can loosen in the early postoperative period. This requires surgery to remove the ICON Modular Fixation System. There have been 484 surgical procedures in which the recalled devices have been implanted. To date, approximately 4% of the constructs have been reported as loose, and this has resulted in the surgical removal or revision of a number of the constructs. No deaths, and no serious injuries other than surgery for device removal have been reported to Blackstone Medical, Inc.

Read the full FDA recall notification regarding Blackstone Medical’s ICON Modular Fixation System.

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