{"schema_version":"secwatch.filing_event.v1","accession":"0000917520-25-000004","form_type":"8-K","ticker":"IART","cik":"0000917520","company_name":"INTEGRA LIFESCIENCES HOLDINGS CORP","filed_at":"2025-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:06.798670+00:00","generated_at":"2026-05-28T12:00:41.655080+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Integra LifeSciences receives FDA warning letter for quality system violations at three facilities","bullets":["FDA warning letter dated Dec 19, 2024, for quality system issues at Mansfield, MA; Plainsboro, NJ; Princeton, NJ facilities.","Products cited: cranial perforators, cottonoid patties, strips, collagen-based products; shipping holds and voluntary recall of patties/strips previously initiated.","Warning letter does not restrict manufacturing/shipment or require recall; premarket approval for related Class III devices blocked until violations resolved.","Company reaffirms Q4 revenue guidance of $441M-$451M; expects no material impact from warning letter.","Company is executing a compliance master plan and preparing a written response to the FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0000917520-25-000004","json":"https://secwatch.observer/filing/0000917520-25-000004.json","markdown":"https://secwatch.observer/filing/0000917520-25-000004.md","text":"https://secwatch.observer/filing/0000917520-25-000004.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/917520/000091752025000004/0000917520-25-000004-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/917520/000091752025000004/iart-20241219.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T12:00:41.655080+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"}