By Colin Kellaher

 

Aziyo Biologics Inc. Tuesday said the bulk of its recalled lot of FiberCel Fiber Viable Bone Matrix bone-repair product was implanted into 113 patients, including eight who have died.

The Silver Spring, Md., biotechnology company, which earlier this month recalled the single donor lot of 154 FiberCel units after some patients tested positive for tuberculosis, said the U.S. Centers for Disease Control and Prevention has identified at least 72 patients who have exhibited clinical or diagnostic findings consistent with tuberculosis infection.

Aziyo said the cause of death of the eight patients who died is still being determined, adding that 136 of the 154 recalled units were implanted in the 113 patients, while 18 have been returned to the company or the CDC.

Aziyo said samples of the recalled product tested positive for Mycobacterium tuberculosis in PCR analysis by a lab contracted by the CDC, adding that the same lab is conducting cell-culture testing of the product to corroborate the PCR testing results.

The company said a review of its processes for screening donors and producing FiberCel hasn't identified any deviations from its established protocols, and that it doesn't believe any other units of FiberCel are affected. Aziyo said the U.S. Food and Drug Administration is conducting an inspection of the company's plant in Richmond, Calif., that produces FiberCel.

Aziyo also said an individual who claims to have contracted tuberculosis following the implantation of Fibercel during a spinal-fusion operation has filed a lawsuit against the company and Medtronic PLC, the exclusive distributor of Fibercel, seeking unspecified compensatory and punitive damages.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 22, 2021 08:09 ET (12:09 GMT)

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