The FDA, CDC and several states are investigating an outbreak of tuberculosis connected to recalled human bone tissue products that were sold to hospitals, surgical centers and dental clinics, the CDC said July 25.
Silver Spring, Md.-based Aziyo Biologics recalled all lots of its human bone tissue products July 13 after two patients contracted tuberculosis. During spinal surgery, both were treated with a viable bone matrix product made from one donor lot, the company said. Before the lot was sold, an independent lab tested samples and found them to be negative for Mycobacterium tuberculosis.
One patient died.
At least 36 patients across seven states have been treated with the human tissue material, according to the agency. The CDC did not disclose if more tuberculosis cases have been reported.
Officials said the outbreak seems to be connected to Aziyo's ViBone, a bone-forming product. Forty-three units of ViBone from the donor have been shipped to hospitals across five states, the CDC told Becker's. Seven units of a dental implant, called alloOss, made from the same donor have been sent to dental offices in four states.
The products were shipped between Feb. 27 and June 20, according to the CDC.
Aziyo said it is "working closely with CDC staff to notify physicians of the patients who received the particular donor lot at issue to initiate post-exposure prophylaxis."
In 2021, Aziyo saw a tuberculosis outbreak from a contaminated bone repair product, which could have included more than 100 patients.