FiberCel Fiber Bone Repair and Bone Graft Material Recalled in Maryland Due to Concerns of Contamination Resulting in Potential Tuberculosis Exposure
If you have recently had a bone repair or bone graft in Maryland it is important you read this.
Aziyo Biologics Inc. has issued a recall for FiberCel Fiber Viable Bone Matrix, a bone repair and bone graft product made from human tissue that is used in various orthopedic and spinal procedures used in spine procedures here in Maryland.
Notice of the voluntary recall was issued to local Maryland hospitals after the company learned of post-surgical infections in patients treated with FiberCel, including some patients that tested positive for tuberculosis. 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.
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.
If you have recently had a surgery involving bone repair or bone graft and contact your doctor or hospital to verify Aziyo was utilized and if so, contact us for further direction as to how to proceed.