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.