FiberCel lawsuit is filed against Aziyo Biologics, Inc., the manufacturer of the allograft bone product FiberCel. The product is made from human tissue that was obtained from one human donor and donated. In orthopedic or bone grafting procedures, the allograft can be used alone as a bone graft or in conjunction with autologous bone or other types of allograft bone.
Aziyo Biologics, Inc. announced an urgent voluntary recall for a particular batch (NMDS210011) of its FiberCel Fiber Viable Bone Matrix product on June 2, 2021. This recall was brought about by a complaint from a single hospital that stated that 7 out of 23 patients who had received FiberCel from this specific lot had experienced post-surgical infections. The fact that four of these patients tested positive for tuberculosis (TB) was even more concerning news.
For every customer who received FiberCel from this specific donor lot, Aziyo's letter acted as a call to action. The directive was to check the inventory right away and quarantine any leftover products. Reports state that approximately 100 patients were exposed to the contaminated FiberCel product that was recalled. The majority of the contaminated products were utilized in fracture repair and spinal surgery procedures. Mycobacterium tuberculosis was discovered to be present in the recalled batch products according to PCR analysis. The next step is to continue cell culture studies in order to confirm that the recalled product was contaminated with Mycobacterium.
The defendants were accused in the FiberCel lawsuit of failing to:
- Gather and review donor medical history appropriately
- Design, manufacture, and test the product to prevent contamination
- Send out a prompt product recall
- Look for Inform customers about the possibility of developing tuberculosis
Aziyo Biologics was accountable for guaranteeing the sterility of the FiberCel Bone Matrix, as stated in the FiberCel lawsuits. The victims were directly infected as a result of the manufacturer's failure to test the product for Mycobacterium contamination.
Aziyo acknowledges that 20 states received 154 FiberCel units from their tainted batch. The business anticipates a surge in injury lawsuits starting in 2024. Anticipating a legal dispute, the business withdrew its most recent revenue projection for 2021. This suggests that the manufacturer is worried about the uncertainty that the tainted product recall and its impact on sales will cause for their business.
Because of tainted FiberCel bone grafts, do you have tuberculosis?
Consult a knowledgeable FiberCel attorney to learn more about your options for pursuing FiberCel lawsuits. Please provide your medical records and proof of the injuries you received from contaminated products.
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