[pending] Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Pending LLM rewrite. Source: FDA_DEVICE Z-0582-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
The recalled product
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 1. Article Number: 440.230V10
- UDI-DI: N/A
- Lot Numbers: EPZM8
- HPT6
- KEWN9
- NAAM6
- VAW80
- 2. Article Number: 475.132V10
- Lot Numbers: CRL56
- HPHJ1
Distribution
Distributed nationwide across the United States.
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