On June 2, 2021, the FDA issued an Urgent Voluntary Notification, in coordination with a voluntary recall by Aziyo Biologics, Inc., a Delaware corporation, instructing any medical facility who received FiberCel product from a single donor lot (Lot Number: NMDS210011) to immediately examine its inventory and quarantine any remaining product.
The notification and voluntary recall follows an investigation of a rare tuberculosis outbreak among more than 100 patients who may have been infected after having spinal surgery or fracture repairs this spring using FiberCel product that was contaminated with the bacteria that causes tuberculosis (“TB”).
Federal and state health officials are recommending that patients who received FiberCel’s bone repair product be treated for TB even if they are not showing symptoms. TB is a bacterial disease caused by Mycobacterium tuberculosis. It usually affects the lungs, but can attack any part of the body, including the kidney, spine and brain. If the disease is not treated properly, it can be fatal. Typical treatment for TB that is not drug-resistant is a six-month course of antibiotics.
What is FiberCel Fiber Viable Bone Matrix?
FiberCel is a fiber-based malleable bone putty that contains human cells and is engineered to maintain the characteristics of natural tissue. It is used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone or alone as a bone graft.
FiberCel and TB – Post-surgery infections?
The typical method of contracting TB is to breathe in the bacteria called “Mycobacterium tuberculosis.” However, in the case of patients who have undergone bone-graft and other orthopedic/reconstruction surgeries, the body can become a safe environment for the TB to reactivate and cause disease. For those with weakened immune systems, the risk of developing TB is much higher than those with normal immune systems.
Next Steps –
If you believe you received FiberCel as part of your (or a loved one’s) orthopedic or reconstructive surgical procedure between March 3 and April 2, 2021, call 302-298-0370 immediately to schedule a free initial consultation, or contact us online. We represent victims throughout Delaware and the surrounding area who have been affected by this and other dangerous and defective products.