FiberCel Surgical Bone Product Lawsuit

FiberCel fiber powder, manufactured by Aziyo Biologics, Inc. and distributed by Medtronic, is a surgical bone product used in orthopedic or reconstructive bone-grafting procedures to help bones regenerate. Unfortunately, a contaminated single lot of FiberCel has been recalled after some implanted patients were found to have post-surgical tuberculosis (TB) infections. If you were diagnosed with TB as a result of FiberCel, you may be able to pursue compensation for your illness.

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FiberCel Surgical Bone Product Lawsuit

Breaking News: FiberCel Recall Linked to Bone Graft Infection

In June 2021, Aziyo Biologics, Inc. issued an urgent voluntary recall of a single lot (NMDS210011) of its FiberCel Fiber Viable Bone Matrix product following a customer complaint from one hospital that initially reported post-surgical infection in 7 of the 23 patients that received FiberCel from this lot. Four of these patients have tested positive for tuberculosis (TB).

So far, more than 100 patients may have been exposed to this contaminated batch of FiberCel after having spinal surgery or fracture repairs.

What Is Tuberculosis?

Tuberculosis is an infectious disease caused by a bacterium called Mycobacterium tuberculosis (MTB), according to the Centers for Disease Control and Prevention (CDC).

Although this bacteria usually attacks the lungs, MTB can also attack any part of the body, including the kidney, spine, and brain. When this bacteria is introduced into a surgical wound, the patient is already in an immunocompromised position, which increases the likelihood of developing TB.

Patients who underwent spinal fusions or fracture repairs using FiberCel from the recalled lot are likely to have been exposed to MTB.

What Is FiberCel?

FiberCel Fiber Viable Bone Matrix is a fiber-based surgical bone repair product made from human tissue and engineered to maintain characteristics of natural tissue to facilitate bone repair and healing.

As a bone and fracture repair product, FiberCel is marketed for use in orthopedic or reconstructive bone-grafting procedures in combination with autologous bone, other forms of allograft bone, or alone as a bone graft.

FiberCel Lawsuits

In June 2021, the first known FiberCel lawsuit was filed in a Delaware state court on behalf of a patient who was diagnosed with tuberculosis after undergoing spinal surgery in April.

This FiberCel lawsuit accuses Aziyo Biologics, Inc. (FiberCel’s manufacturer) and Medtronic (the exclusive distributor) of failing to:

  • Adequately obtain and review donor medical history
  • Design, manufacture, and test the product to ensure it was free from contamination
  • Issue a timely recall of the product
  • Warn consumers of the risk of contracting tuberculosis

FiberCel Lawsuit Settlements and Verdicts

If you were diagnosed with tuberculosis after surgery, you may be able to pursue compensation from a lawsuit, which usually can come in one of two forms:

  • FiberCel Settlements: A FiberCel settlement can be reached if the defendant makes you a financial offer before going to court, which can allow you to receive compensation sooner.
  • FiberCel Verdicts: If your case does go to court, a judge and jury will hear your case and reach a verdict that determines an amount of compensation for your injuries.

Get Legal Help Pursuing a Surgical Bone Product Settlement

If you underwent an orthopedic or spinal surgery that used FiberCel and were later diagnosed with tuberculosis, you may be able to pursue compensation for your illness and hold the manufacturers of this contaminated product responsible for their negligence — and Sokolove Law may be able to help.

As an established personal injury law firm, we have over 40 years of experience helping people like you hold companies accountable for their negligence and wrongdoings.

Get a free case review or call (800) 995-1212 to learn more about your legal options.

FiberCel Lawsuit FAQs

Why was FiberCel recalled?

The bone repair product manufacturer recalled one lot of FiberCel after realizing the lot had been contaminated with the bacteria that cause tuberculosis.

Author:Sokolove Law Team
Sokolove Law Team

Contributing Authors

The Sokolove Law Content Team is made up of writers, editors, and journalists. We work with case managers and attorneys to keep site information up to date and accurate. Our site has a wealth of resources available for victims of wrongdoing and their families.

Last modified: July 7, 2021

View 4 Sources
  1. Aziyo Biologics. “Aziyo Biologics Announces Exclusive Agreement with Medtronic to Distribute FiberCel.” Retrieved from: https://www.aziyo.com/aziyo-biologics-announces-exclusive-agreement-with-medtronic-to-distribute-fibercel/. Accessed on July 1, 2021.
  2. Centers for Disease Control and Prevention (CDC). “Basic TB Facts.” Retrieved from: https://www.cdc.gov/tb/topic/basics/default.htm. Accessed on July 1, 2021.
  3. PR Newswire. “First U.S. Lawsuit Filed Against Aziyo Biologics Inc. and Medtronic Inc. On Behalf of Delaware Patient Infected with Tuberculosis After Receiving Tainted Surgical Bone Graft Product During Spinal Fusion.” Retrieved from: https://www.prnewswire.com/news-releases/first-us-lawsuit-filed-against-aziyo-biologics-inc-and-medtronic-inc-on-behalf-of-delaware-patient-infected-with-tuberculosis-after-receiving-tainted-surgical-bone-graft-product-during-spinal-fusion-301314230.html. Accessed on July 1, 2021.
  4. Washington Post. “CDC Investigating TB cases linked to tainted bone repair product used in more than 100 patients.” Retrieved from: https://www.washingtonpost.com/health/2021/06/18/tb-bone-product/. Accessed on July 1, 2021.