regulatory
confidence high
sentiment negative
materiality 0.85
Aziyo voluntarily recalls viable bone matrix products after two MTB infections
ELUTIA INC.
- 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.