Medtronic Terminates Distribution Agreement for Aziyo’s Cellular Bone Matrix Products

Medtronic will no longer distribute cellular bone matrix products from Aziyo Biologics.

The decision comes after a single batch of Aziyo’s FiberCel products was recalled in June after several patients who received it tested positive for tuberculosis. Several lawsuits have been filed on behalf of patients who allegedly became ill or died from a contaminated product.

“After careful consideration 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. “Following 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 impacted by the June 2, 2021 FiberCel single-lot recall.”

Aziyo President and CEO Ron Lloyd said the company will continue to support patients affected by the recall.

“While we are disappointed that Medtronic has 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 who have been impacted by the previously announced recall of a single donor lot of this product,” Mr. Lloyd said in an October 25 press release.

Mr Lloyd also said the company has developed and implemented safety measures for future production batches. Strategies include additional donor screening and the development of m.tuberculosis screening methods.

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