FiberCel Viable Bone Matrix Recall: FDA Alerts Public That Certain FiberCel Lots Have Been Recalled.
On June 2, 2021, the United States Food and Drug Administration (FDA) announced that Aziyo Biologics, Inc., (“Aziyo”) was voluntarily recalling a Lot (Lot Number: NMDS210011) of FiberCel Fiber Viable Bone Matrix (“FiberCel”) in response to a customer complaint from a hospital that reported post-surgical infection in 7 of the 23 patients who received FiberCel Fiber Viable Bone Matrix from this particular lot, including 4 who reportedly tested positive for Tuberculosis. Aziyo, based in Richmond, California, is reportedly the manufacturer of record for FiberCel.
FiberCel Fiber Viable Bone Matrix is a fiber-based bone repair product created from human tissue (that contains cancellous bone particles with preserved living cells and demineralized cortical bone fibers) that is used in orthopedic, spinal or reconstructive bone grafting procedures along with autologous bone and/or allograft bone or by itself as a bone graft.