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.
The CDC warned in a statement that patients who underwent spinal fusions or fracture repairs using the recalled lot of FiberCel are "likely to have been exposed to mycobacterium tuberculosis", which can cause severe disease and death if untreated.The agency is recommending that surgeons should work with their respective health department's TB programs to immediately contact patients who underwent surgery using the recalled product.Indiana state health officials are investigating 30 individuals in 19 counties who received the bone repair product.
In Delaware, 23 patients received the bone repair products, an anonymous source familiar with the investigation told the Post.Fenimore told the outlet that state health officials received notification in late May from a healthcare system about a cluster of patients who developed tuberculosis after surgery 'involving a specific product.'.
The lawsuit states that after Aziyo's voluntary recall was issued, Williams had a second surgery to remove the contaminated product and insert new bone five days later.
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