Aziyo Biologics Recalls One Lot of FiberCel Fiber Viable Bone Matrix

Aziyo Biologics Inc. last week issued a voluntary recall for a single donor lot of its FiberCel Fiber Viable Bone Matrix, a bone repair product made from human tissue that is used in various orthopedic and spinal procedures.

“Patient health and safety are our highest priority. Accordingly, we have implemented this voluntary recall and instructed hospitals that received FiberCel product from this specific donor lot to immediately quarantine and return any remaining product to us,” said Ron Lloyd, Aziyo’s president and CEO. “We are committed to a thorough, timely and transparent investigation into the root cause of these infections.”
 
Notice of the voluntary recall was issued to hospitals that received product from this specific lot after the company learned of post-surgical infections in patients treated with FiberCel, including some patients that tested positive for tuberculosis. The lot consists of 154 units of FiberCel, all derived from a single donor, that were shipped to facilities in 20 states. Aziyo is investigating the source of the infections in coordination with its distributor, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. The company is in the process of recovering the unused units from this lot. The company currently does not believe any other units of FiberCel are affected.
 
According to the CDC, tuberculosis is caused by a bacterium called Mycobacterium tuberculosis. Because tuberculosis is a communicable disease, infection needs to be reported to the local or state health department tuberculosis program, and is treated with a combination of antibiotics.
 
Out of an abundance of caution, sales of FiberCel will be suspended by its distributor until further notice. Given the uncertainty regarding any potential impact to Aziyo’s business resulting from the recall and the pause in FiberCel sales, Aziyo is suspending its revenue guidance for full year 2021, previously announced on May 4.
 
FiberCel is a fiber-based bone repair product made from human tissue and engineered to maintain characteristics of natural tissue. It is marketed for use 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 provides handling properties that are critical for use as a bone void filler in various orthopedic and spinal procedures. FiberCel contains cancellous bone particles with preserved living cells and demineralized cortical bone fibers to facilitate bone repair and healing.