The case, Elutia Inc. v. Medtronic Sofamor Danek USA, Inc., stems from a January 24, 2019, Tissue Product Provide Settlement. Beneath the contract, Elutia agreed to produce FiberCel, a bone matrix product, to Medtronic for distribution. In June 2021, a single lot of the product was recalled after allegations that it prompted sufferers to contract tuberculosis. Of the 154 models recalled, Medtronic had distributed 136, which had been implanted in 113 sufferers. Starting in September 2021, greater than 100 lawsuits adopted, naming each corporations as defendants in most of the circumstances.
