Blackstone Medical, Inc. Issues Voluntary Recall of ICON(tm) Modular Fixation System

The Food and Drug Administration (FDA) released the following information:

Blackstone Medical, Inc. Issues Voluntary Recall of ICON(tm) Modular Fixation System
Contact:
Diane Johnson
(888) 298-5400

On December 27, 2005 Blackstone Medical, Inc. informed the FDA of a voluntary recall of its ICON(tm) Modular Fixation System.  A notice was sent the same day to distributors and surgeons implanting the ICON(tm) Modular Fixation System. The product has been marketed since June, 2005. Components in the system may fail after the devices have been implanted.

This voluntary recall, subsequently classified as a Class I recall by the FDA on April 7th, 2006, includes components of system 54-9011. Blackstone Medical, Inc. initiated the recall after receiving reports of construct loosening in the early postoperative period. Blackstone Medical, Inc. verified the removal from distribution of remaining affected products that were not yet implanted.

The ICON(tm) 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. The potential for injury due to failure of the implant will depend on the specific condition being treated, and the degree of postoperative healing. There may be potential for serious injury in specific patients.

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. Blackstone Medical, Inc, believes it is unlikely that the loosening will continue to occur now that patients are later in the post-operative period. The affected ICON(tm) Modular Fixation System products were distributed and used in both the U.S. and Germany.

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(tm) fixation devices should contact the physician who is providing postoperative care.


Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.