Straumann USA LLC: Device Recall
Recall #Z-0582-2026 · 10/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0582-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Straumann USA LLC
- Status
- Ongoing
- Date Initiated
- 10/17/2025
- Location
- Andover, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Reason for Recall
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Product Description
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Other Recalls by Straumann USA LLC
- Class II: Risk 05/01/2025
- Class II: Risk 05/01/2025
- Class II: Risk 04/17/2025
- Class II: Risk 04/14/2025
- Class II: Risk 03/08/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.