Aziyo Says Most or Recalled FiberCel Lot Already Implanted
June 22 2021 - 8:14AM
Dow Jones News
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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