secwatch.observer — SEC 8-K summary
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Issuer:     ELUTIA INC. (ELUT)
CIK:        0001708527
Form:       8-K
Filed at:   2023-07-13T23:59:59+00:00
Accession:  0001104659-23-080808
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aziyo voluntarily recalls viable bone matrix products after two MTB infections
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1708527/000110465923080808/0001104659-23-080808-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1708527/000110465923080808/tm2321274d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-080808

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer