FDAHealthOctober 17, 2025
Straumann USA LLC — Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
⚠️ The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 17, 2025
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
What's affected?
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Brand
- Straumann USA LLC
- Lot code
- EPZM8
Additional details
1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 61 units.
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