1. Elutia, formerly Aziyo Biologics, recalled its viable bone matrix products in July after two patients were infected with Mycobacterium tuberculosis following surgeries. The voluntary recall stems from infections from a single donor lot. The company is working with the FDA and CDC to investigate.
2. The FDA issued a Class I recall of Abbott Medical’s implantable Abbott Proclaim neurostimulation systems, designed to deliver low-intensity electrical impulses to nerve structures for spinal cord stimulation. The recall affects 155,028 devices distributed between Nov. 21, 2015, and June 29, according to an FDA recall notice initiated by Abbott July 18. Abbott said in a statement shared with Becker’s that no products need to be returned or replaced.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
