FDA Recall: ICON Modular Pedicle Screw System

It was reported in the August 5th, 2009 "Gray Sheet" that the I-CON Modular Pedicle Screw System was being recalled by Blackstone Medical. The firm initiated the recall via e-mails on May 21, 2009 and letters on May 26,209. Isn't this the same system that was recalled a few winters ago? The reason for the recall was noted: "Product marketed without an approved 510(k). The recall number is Z-1655-2009

On December 23rd, 2005, Blackstone Medical (BO, Before Orthofix), initiated a recall because there were reports that the screws were loosening from the screwheads post-op. On January 26, 2007 there was a MAUDE Adverse Event Report, the screws backed out at L5. The surgeon replaced the I-CON with Medtronic Screws. On 3/13/09, Orthofix/Blackstone received a WARNING LETTER from the FDA from the Inspection, Compliance Enforcement, Criminal Investigations unit for violations pertaining to the I-CON. The violations are listed under the warning letter NWE-09-09W. Maybe it's time Orthofix take the I-CON and shelve the product. Considering that many Blackstone employees complained about the original design, it's a wonder this product has lasted this long. The Spine Blogger wants to know what any of you have heard on the street. Sometimes, old news is good news.