Components in the system may fail after the devices have been implanted. A previous voluntary recall that was initiated on December 23, 2005, has now been upgraded to a Class I recall. On December 27, 2005, Blackstone Medical, Inc. of Springfield, Massachusetts, informed the FDA of a voluntary recall of its ICON™ Modular Fixation System . That same day, the company sent a notice to distributors and surgeons implanting the system that has been marketed since June, 2005.
The recall was initiated because components in the system may fail after the devices have been implanted. Blackstone Medical took the action after receiving reports of construct loosening in the early postoperative period.
The company “verified the removal from distribution of remaining affected products that were not yet implanted.” The upgraded voluntary recall classified as a Class I recall by the FDA on April 7th, 2006, includes components of system 54-9011.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Intended to immobilize and stabilize spinal segments at the site of spine surgery
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.”
According to the FDA, 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.”
“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. Records indicate that 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. The company believes it is unlikely that the loosening will continue to occur now that patients are later in the post-operative period.
Affected ICON™ Modular Fixation System products were distributed and used in both the U.S. and Germany
The affected ICON™ Modular Fixation System products were distributed and used in both the U.S. and Germany. The models involved are #54-1090; 54-1091; 54-1092, distributed between June and December 2005.
Blackstone Medical 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.”
Patients who have had spinal surgery since June 2005 and are not sure whether or not they were implanted with the recalled device should contact their doctor to discuss any concerns they may have about this recall. Physicians and patients who have questions about the recall may contact Blackstone Medical Customer Service at 888-298-5400.