Aziyo Biologics, Inc. issued a voluntary recall on June 2, 2021 pertaining to a single donor lot of its FiberCel Fiber Viable Bone Matrix after learning of post-surgical infections in several patients treated with the product, including some patients that tested positive for tuberculosis. Samples of the recalled product have now undergone PCR analysis by a lab contracted by the CDC and tested positive for Mycobacterium tuberculosis. Cell culture testing of the recalled product is being conducted by the same lab to corroborate the PCR testing results.
Based on information from the CDC, 136 units within this product lot were implanted into 113 patients in 20 states. Of the 113 patients, the CDC has identified at least 72 patients who have exhibited clinical or diagnostic findings consistent with tuberculosis infection. Eight patients who received the product from this lot have died. However, the cause of death is still being determined. Working with state health agencies, the CDC has contacted all patients treated with this lot of FiberCel to help ensure they are directed to appropriate medical treatment.
Contact us immediately if you recently underwent spinal surgery and have since been diagnosed with tuberculosis or contacted by health agencies about tainted bone graft material. We are helping victims of this recall nationwide.
FiberCel Bone Graft Injury FAQs
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, call 302.655.2599 or fill out this form immediately.
Verdicts and Settlements
- $2.2 million settlement: a man who, while in the course and scope of his employment, lost both legs when struck on the side of the road by a truck driver
- $2.1 million settlement: Navy SEAL struck by a driver who left the roadway, causing serious injuries to his legs
- $875,000 settlement: bicyclist who injured an eye when struck by a teenage car driver
- $850,000 settlement: young lady injured her shoulder in a multi-car accident which resulted in surgery, lost earnings, and medical expenses
- $615,000 settlement: 47-year-old man struck by a car while changing a tire, resulting in a significant arm injury
- $500,000 settlement: wrongful death claim where the defendant crossed the center line, killing the mother of 5 adult children
- $445,000 settlement: 60-year-old tractor-trailer driver rear-ended by another tractor-trailer, resulting in neck and back surgeries
- $350,000 settlement: 44-year-old woman who suffered orthopedic injuries resulting in surgery as a result of a motor vehicle accident
- $297,500 settlement: policy limits wrongful death settlement arising out of a motor vehicle accident
- $250,000 settlement: 51-year-old man who suffered a neck injury requiring surgery as a result of a motor vehicle accident
- $220,000 settlement: 46-year-old female cafeteria worker, injured low back lifting a tray of juice and subsequently diagnosed with failed back syndrome
- $205,000 settlement: 32-year-old male maintenance worker sustained low back injury while moving a trash dumpster, requiring multiple surgeries
- $164,990 settlement: 49-year-old male bus driver sustained low back and knee injuries when the bus hit a deep pothole, resulting in knee replacement surgery
- $125,000 settlement: 66-year-old woman who suffered an eye injury as a result of a trip and fall at a retail store
- $90,000 jury verdict: 44-year-old man rear-ended in an automobile accident resulting in muscular injuries and an elbow nerve injury
- January 6, 2023
- May 19, 2022
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- November 10, 2021
- July 7, 2021
- First Florida Tuberculosis-Tainted Surgical Case Among the Latest Filed Against Aziyo Biologics, Inc.July 2, 2021
- CDC, FDA investigating rare tuberculosis outbreak potentially linked to contaminated bone repair productJune 21, 2021Fox News
- June 19, 2021Washington Post