Aziyo Biologics announced a voluntary recall of viable bone matrices, which are bone repair products made from human tissue that are used primarily in orthopedic and spinal procedures.
Notice of the voluntary recall was issued to centers after the company learned of post-surgical Mycobacterium tuberculosis (MTB) infections in two patients treated with viable bone matrix product from a single donor lot. Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically detect the MTB organism. Aziyo is fully cooperating and investigating the events in coordination with the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention.
Out of an abundance of caution, the company has suspended shipments of all viable bone matrix products from all donor lots. The company is also working closely with CDC staff to notify physicians of the patients who received the particular donor lot at issue to initiate post-exposure prophylaxis.
“We are taking immediate action to safeguard patients by implementing a full product recall as we work with the CDC to investigate this event,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics. “The people of Aziyo care deeply about the patients we serve and will continue to work with the medical community, patients, and regulatory authorities as we gather additional information.”
Aziyo Biologics announced a voluntary recall of viable bone matrices, which are bone repair products made from human tissue that are used primarily in orthopedic and spinal procedures.
Notice of the voluntary recall was issued to centers after the company learned of post-surgical Mycobacterium tuberculosis (MTB) infections in two patients...
Aziyo Biologics announced a voluntary recall of viable bone matrices, which are bone repair products made from human tissue that are used primarily in orthopedic and spinal procedures.
Notice of the voluntary recall was issued to centers after the company learned of post-surgical Mycobacterium tuberculosis (MTB) infections in two patients treated with viable bone matrix product from a single donor lot. Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically detect the MTB organism. Aziyo is fully cooperating and investigating the events in coordination with the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention.
Out of an abundance of caution, the company has suspended shipments of all viable bone matrix products from all donor lots. The company is also working closely with CDC staff to notify physicians of the patients who received the particular donor lot at issue to initiate post-exposure prophylaxis.
“We are taking immediate action to safeguard patients by implementing a full product recall as we work with the CDC to investigate this event,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics. “The people of Aziyo care deeply about the patients we serve and will continue to work with the medical community, patients, and regulatory authorities as we gather additional information.”
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