This recall follows a customer complaint from one hospital that reported post-surgical infection in seven of the 23 patients that have received FiberCel from this Donor Lot. Four of these patients have tested positive for tuberculosis.
Aziyo Biologics, Inc., a Delaware corporation, with operations in California and Maryland, issued an urgent notification letter on June 2, 2021 instructing any medical facility who received FiberCel product from this single donor lot to immediately examine its inventory and quarantine any remaining product.
You don’t pay us until we win.
If you believe you received FiberCel as part of your (or a loved one’s) medical treatment, such as a bone graft for orthopedic or reconstructive purposes, SM&B is committed to obtaining all the results you need and deserve. Contact us today.
What is FiberCel Fiber Viable Bone Matrix?
FiberCel is a fiber-based bone repair product made from human tissue and engineered to maintain 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.
Additionally, 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.
FiberCel and Tuberculosis – Post-surgery infection risks?
The typical method of contracting tuberculosis is to breathe in the bacteria called “Mycobacterium tuberculosis.” However, in the case of patients with bone-graft and other orthopedic/reconstruction surgeries, their bodies may be more susceptible to infections of all kinds and the tuberculosis bacteria, if included in the lot of FiberCell bone grafts, could find a suitable host in which to proliferate.
FiberCell was used in my procedure – what should I do?
If you believe you received FiberCel as part of your (or a loved one’s) medical treatment, such as a bone graft for orthopedic or reconstructive purposes, and have developed an infection or tuberculosis, contact us immediately.