CDC, FDA investigating rare tuberculosis outbreak potentially linked to contaminated bone repair product

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The recalled product, a malleable bone putty known as FiberCel, was shipped to 37 facilities across 20 states, according to the CDC

The Centers for Disease Control and Prevention, Food and Drug Administration and state and local health agencies are investigating the origin of a rare, multi-state tuberculosis outbreak after more than 100 patients may have been infected during spinal surgery or fracture repairs this past spring.

The procedures used a bone repair product called FiberCel Fiber Viable Bone Matrix, a malleable bone putty developed by regenerative medicine company Aziyo Biologics which uses human cells and is used in a variety of orthopedic procedures, according to the Washington Post.

Aziyo issued a voluntary recall notice on June 2 of 154 units of FiberCel, all derived from a single donor, that were shipped to 37 facilities across 20 states, according to the CDC. The Post reported that a total of 113 patients received the recalled product, with eight patients dying after their procedures, though the cause of death is still being determined.

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