Michael Barbella, Managing Editor07.14.23
Aziyo Biologics Inc. has initiated a voluntary recall of its viable bone matrix products.
The affected products are bone repair solutions made from human tissue, used primarily in orthopedic and spinal procedures.
Aziyo Biologics issued the voluntary recall notice to centers after learning of post-surgical mycobacterium tuberculosis (MTB) infections in two patients treated with viable bone matrix product from a single donor lot. Before its release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test designed to specifically detect the MTB organism. Aziyo Biologics 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 (CDC).
Out of an abundance of caution, the company has suspended shipments of all viable bone matrix products from all donor lots. Aziyo Biologics 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,” Aziyo Biologics President and CEO Dr. Randy Mills said. “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 develops and commercializes biologic products to improve compatibility between medical devices and patients. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes.
The affected products are bone repair solutions made from human tissue, used primarily in orthopedic and spinal procedures.
Aziyo Biologics issued the voluntary recall notice to centers after learning of post-surgical mycobacterium tuberculosis (MTB) infections in two patients treated with viable bone matrix product from a single donor lot. Before its release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test designed to specifically detect the MTB organism. Aziyo Biologics 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 (CDC).
Out of an abundance of caution, the company has suspended shipments of all viable bone matrix products from all donor lots. Aziyo Biologics 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,” Aziyo Biologics President and CEO Dr. Randy Mills said. “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 develops and commercializes biologic products to improve compatibility between medical devices and patients. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes.