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U.S. Department of Health and Human Services

Safety

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Blackstone Medical ICON Modular Fixation System

Audience: Neurosurgical healthcare professionals, surgical service managers and hospital risk managers

[Posted 04/17/2006] Blackstone Medical, Inc. and FDA notified healthcare professionals about a recall of its ICON Modular Fixation System, 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.  The pedicle (vertebra stem) screws may separate from the screw heads, or from the rods that run between spinal segments. If this happens soon after the surgery, the spine may not fuse properly, and patients may need additional surgery to correct the problem. If not corrected, some patients may experience long-term pain and disability. The potential for injury depends on the specific condition being treated, and the degree of postoperative healing.  Blackstone Medical, Inc. is requesting that hospitals and surgeons review their records to identify patients who have the recalled products, and to contact these patients.  Patients who may have concerns regarding their ICON fixation devices should contact the physician who is providing postoperative care.

[April 17, 2006 - Class 1 Recall - FDA]