Parker Waichman LLP

FDA Announces Class I Recall of ICON™ Modular Fixation System from Blackstone Medical, Inc.

Modular Fixation 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 […]

Modular Fixation System

Modular Fixation 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.

Need Legal Help Regarding Modular Fixation System?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

[sc name=”post-footers”]

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Paralegal Tina assisted me in securing a settlement from VCF World Trade Center. Her performance was totally professional and thorough I would recommend her service to anyone.
reginald peavy
10 months ago
5 Star Reviews 150
I can't thank Yesenia and the team at Parker Waichman for helping me with my case. I was treated with the most professional help and respect. I can't thank them enough for handling everything without ease and always keeping me updated on my case. This was my first case dealing with lawyers and Yesenia guided me and was very knowledgable. Thank you again to her and everyone at Parker Waichman!
Perry Shum
4 years ago
5 Star Reviews 150
Great attorneys
Doug Whitman
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038