Medtronic will no longer distribute Aziyo Biologics' cellular bone matrix products.
The decision comes after a single lot of Aziyo's FiberCel product was recalled in June after several patients who received it tested positive for tuberculosis. Multiple lawsuits were filed on behalf of patients who allegedly were sickened or died from a tainted product.
"After a thorough review of customer and patient needs, Medtronic has made the decision to cease distribution of Cellular Bone Matrix products at this time," Medtronic said in an Oct. 25 email to Becker's. "As a result of this decision, we are working with Aziyo to mutually terminate our FiberCel distribution agreement. We will continue to work with Aziyo to support patients and customers affected by the June 2, 2021 single-lot FiberCel recall."
Aziyo's president and CEO Ron Lloyd said the company will continue to support patients affected by the recall.
"While we are disappointed that Medtronic made the decision to cease distribution of Cellular Bone Matrix products, including Aziyo’s FiberCel Fiber Viable Bone Matrix, we will continue to collaborate and mutually support patients that were impacted by the previously announced recall of a single donor lot of this product," Mr. Lloyd said in an Oct. 25 news release.
Mr. Lloyd also said the company has developed and implemented safety measures for future production lots. The strategies include additional donor screening and developing methods of testing for m.tuberculosis.