Straumann USA LLC: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Straumann USA LLC
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Reason / hazard
- The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
- Recall initiated
- 2025-10-17
- Code info
- 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;
- Product quantity
- 61 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 97753
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