On June 2, 2021, The United States Food and Drug Administration notified the public that the manufacturer of FiberCel Fiber Viable Bone Matrix recalled a contaminated Lot of the product. The FiberCel product is used to promote bone repair and healing, often in spine surgery. FiberCel is manufactured by Aziyo Biologics, Inc. and distributed by Medtronic. The contaminated product was most likely used during medical procedures taking place in the first or second quarter of 2021.
FiberCel Lot NMDS210011 is potentially contaminated with the bacteria causing Tuberculosis and can potentially cause patients who received FIberCel Bone Matrix from the contaminated Lot to acquire Tuberculosis. Aziyo has advised that one hospital reported post-surgical infection in 7 out of 23 patients that received FIberCel from the contaminated Lot and that four of those patients tested positive for Tuberculosis.
Randall & Schumacher, PA has over 25 years of experience in representing individuals injured by medical products, including medical devices, pharmaceuticals, and blood products. If you believe you were treated with, or you have been told by a medical professional that you were treated with FIberCel Fiber Viable Bone Matrix please contact us for a free consultation.