Recall Z-0582-2026— Straumann USA LLC
Class II · Ongoing
Class II FDA medical device recall by Straumann USA LLC, initiated 2025-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;. Reason: The possibility for this product that is intended for demonstration purposes only to be placed in patients..
- Recalling firm
- Straumann USA LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-17
- Firm location
- Andover, MA, United States
Product description
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Reason for recall
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.