On June 2nd, 2021, the US Food & Drug Administration (FDA) announced the voluntary recall of Aziyo Biologics’ FiberCel Fiber Viable Bone Matrix.
The urgent notification came after one of Aziyo’s customers, a hospital, complained that 7 of 23 patients that had received the FiberCel Fiber Viable Bone Matrix graft had developed a post-surgical infection. Of those, four were tested and found to be positive for tuberculosis.
Tuberculosis, often referred to as tb, is a potentially deadly infectious disease that attacks the lungs. It is highly contagious and, if it cannot be properly contained, can wreak havoc on a hospital’s population.
For the time being, sales of FiberCel were voluntarily suspended by the manufacturer. Only one donor lot is believed to be responsible for the infections. All customers who are recorded as having taken delivery of said lot were ordered to quarantine the product and ship it back to Aziyo as soon as possible. Affected patients should have also been notified by the hospital of the increased health risks.
The team at Hovde Dassow + Deets is investigating several of these claims for patients who contracted tb following surgery. Our team of experienced attorneys is able to get to the bottom of these complex issues and fight to get victims the justice they deserve. Victims or their families may contact us for a free consultation.