Aziyo Biologics is recalling its viable bone matrix products after two patients were infected with Mycobacterium tuberculosis following surgeries, the orthobiologics company said July 13.
The voluntary recall stems from infections from a single donor lot, according to a news release. Before release, samples from the lot had tested negative for tuberculosis.
Aziyo Biologics is cooperating and investigating with the FDA and CDC, the company said. Shipping for all viable bone matrix products from all donor lots was suspended. Aziyo Biologics is also working to notify patients who received bone matrix products from the affected donor lot.
Two years ago, Aziyo Biologics recalled another bone repair product, FiberCel, after multiple patients tested positive for tuberculosis.