![]() ![]() The FDA can take “a number of enforcement actions” when human cell and tissue products don’t comply with its requirements, the spokesperson said, though it typically focuses on voluntary compliance first. The company did not respond to requests for additional comment.Īn FDA spokesperson said in a statement Tuesday that the agency is collaborating with the CDC “to fully understand the impact of this recall.” Two years ago, Aziyo issued a voluntary recall for a different bone-repair product contaminated with the bacteria that causes TB after it was linked to the death of eight patients.Īziyo said in a July 13 statement that samples from the donor lot in question tested negative for TB at an independent lab. The CDC said the materials were sent to California, Michigan, New York, Oregon, Texas and Virginia.Īziyo Biologic issued a recall earlier this month of its bone matrix products - materials made from human tissue typically used in orthopedic and spinal surgeries. The CDC announced the new cases Wednesday, adding to two cases - of which one was fatal - previously identified by health officials.īut the materials suspected to be contaminated have been used in other surgical or dental procedures for patients outside of the known five cases, with at least 36 people being treated as if they have TB. ![]() MORE POSITIVE TB TESTS - Contaminated bone graft materials have been linked to three more patients testing positive for tuberculosis, POLITICO’s Alice Miranda Ollstein and Lauren Gardner report. ![]() have been traced to bone graft material manufactured by Aziyo Biologics. The CDC reports that five TB cases in the U.S. ![]()
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