{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-080808","form_type":"8-K","ticker":"ELUT","cik":"0001708527","company_name":"ELUTIA INC.","filed_at":"2023-07-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.937481+00:00","generated_at":"2026-06-13T08:47:12.032268+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Aziyo voluntarily recalls viable bone matrix products after two MTB infections","bullets":["Voluntary recall of all viable bone matrix products used in orthopedic/spinal procedures.","Two patients treated with product from a single donor lot developed post-surgical Mycobacterium tuberculosis infections.","Shipments of all viable bone matrix products from all donor lots suspended out of caution.","Company coordinating with FDA and CDC to investigate source and notify physicians for post-exposure prophylaxis."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-080808","json":"https://secwatch.observer/filing/0001104659-23-080808.json","markdown":"https://secwatch.observer/filing/0001104659-23-080808.md","text":"https://secwatch.observer/filing/0001104659-23-080808.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1708527/000110465923080808/0001104659-23-080808-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1708527/000110465923080808/tm2321274d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T08:47:12.032268+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}