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 been contacted by health agencies in connection with tainted bone graft material. We are helping victims of this recall nationwide.
- 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
- June 16, 2021
- June 21, 2021
- September 8, 2020
- September 19, 2017
- July 24, 2017
- June 6, 2017
- May 22, 2017
- May 22, 2017
- June 27, 2016
- "I was very comfortable in an uneasy situation."
Kylie was always very professional, courteous, prompt to respond and very helpful. I felt very comfortable when dealing with her. What I liked best about the PI Group was their promptness and they are very professional. I was very comfortable in an uneasy situation. I am sure this was a small case for the office, but the instructions with all involved did not reflect that.
- "This firm was extremely helpful and made the process less stressful."
Every question was answered with a smile. The receptionist always greeted me right when I walked in. Emails were answered quickly and the attorney informed me of everything he was doing. My attorney told me about every step and made sure I understood everything that was going on. This Firm was extremely helpful and made the process less stressful. I couldn't thank you enough. The whole process was stress-free. The attorney kept amazing contact with me, and was very friendly with all of his questions and concerns. All of this is what would encourage me to recommend this service to my family.