Aziyo Biologics, Inc. issued a voluntary recall on June 2, 2021 pertaining to a single donor lot of its FiberCel Fiber Viable Bone Matrix after learning of post-surgical infections in several patients treated with the product, including some patients that tested positive for tuberculosis. Samples of the recalled product have now undergone PCR analysis by a lab contracted by the CDC and tested positive for Mycobacterium tuberculosis. Cell culture testing of the recalled product is being conducted by the same lab to corroborate the PCR testing results.
Based on information from the CDC, 136 units within this product lot were implanted into 113 patients in 20 states. Of the 113 patients, the CDC has identified at least 72 patients who have exhibited clinical or diagnostic findings consistent with tuberculosis infection. Eight patients who received the product from this lot have died, however, the cause of death is still being determined. Working with state health agencies, the CDC has contacted all patients treated with this lot of FiberCel to help ensure they are directed to appropriate medical treatment.
Contact us immediately if you recently underwent spinal surgery and have since been diagnosed with tuberculosis or been contacted by health agencies in connection with tainted bone graft material. We are helping victims of this recall nationwide.
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