Elutia, formerly Aziyo Biologics, has continued to face litigation related to spine biologics allegedly linked to tuberculosis infections that were recalled in recent years.
Here are seven key events to know:
June 2021
Aziyo Biologics voluntarily recalled a lot of its FiberCel product after several patients who received it tested positive for tuberculosis, according to the FDA. At least 91 individuals were treated for TB related to those implants.
July 2021
Lawsuits on behalf of patients affected by tainted allografts started adding up. Affected patients included a man in his 40s who had to have additional surgery following the infection.
August 2022
An investigation by the CDC and the FDA published in The Lancet revealed new details about a tuberculosis outbreak stemming from spinal allografts. Those units were distributed to 37 healthcare facilities across 20 states between March 1 and April 2, 2021. A total of 113 patients had those allografts implanted, and the remaining 18 were located and sequestered. Eight patients died within eight to 99 days of implantation, and three of those deaths happened after the outbreak was recognized.
July 2023
Aziyo Biologics recalled its viable bone matrix products after two patients were infected with Mycobacterium tuberculosis following surgeries. The voluntary recall stems from infections from a single donor lot. Before release, samples from the lot had tested negative for tuberculosis.
September 2023
Aziyo Biologics rebranded as Elutia, referring to its focus on drug eluting biomatrices. The company was previously in talks to divest its orthopedic business.
December 2023
Legislation was introduced in the U.S. House that would require all bone graft material to be tested for active and latent tuberculosis. It would also expedite the process for developing a screening test. The bill, sponsored by two Democratic and one Republican lawmakers, comes following the deaths of two patients who developed tuberculosis linked to tainted bone grafts.
August 2024
A couple has filed a lawsuit against biotech company Elutia, formerly known as Aziyo Biologics, alleging that one member of the couple contracted tuberculosis from the FiberCel implant. Elutia did not respond to Becker's request for comment.