The case, Elutia Inc. v. Medtronic Sofamor Danek USA, Inc., stems from a January 24, 2019, Tissue Product Supply Agreement. Under the contract, Elutia agreed to supply FiberCel, a bone matrix product, to Medtronic for distribution. In June 2021, a single lot of the product was recalled after allegations that it caused patients to contract tuberculosis. Of the 154 units recalled, Medtronic had distributed 136, which were implanted in 113 patients. Beginning in September 2021, more than 100 lawsuits followed, naming both companies as defendants in many of the cases.
