Class 1 Medical Device Recalls - Blackstone Medical, Inc. ICON® Modular Spinal Fixation System

Date Recall
Initiated:

December 23, 2005

Product:

ICON Modular Spinal Fixation System
(Model #54-1090; 54-1091; 54-1092, distributed between June and December 2005)

Use:

The ICON Modular Spinal Fixation System contains a variety of screws, rods and connectors implanted in and near the patient's spine to immobilize and stabilize spinal segments at the site of spine surgery.

Recalling Firm:

Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104-3206

Reason for Recall:

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.

Public Contact:

Diane M. Johnson
Group VP, President, Non Fusion
Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104-3206
(888) 298-5400

FDA District:

New England

FDA Comments:

• Blackstone Medical initiated this voluntary recall in December 2005 in response to reports of the device loosening early in the postoperative period . FDA subsequently classified the recall as a Class I recall. 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.
• Blackstone sent a notice to distributors and surgeons implanting the ICON™ Modular Fixation System on December 27, 2005, recommending that they contact patients who have been implanted with this device.
• Patients who received a notice from their doctor that the recalled device was implanted during their spinal surgery should contact their doctor to discuss their treatment. It may or may not be necessary to replace the device, depending on each individual patient’s circumstances.
• 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.
• Blackstone Medical, Inc. has verified the removal from distribution of remaining affected products that were not yet implanted.

A copy of the company's press release regarding this recall is available at http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html.