Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Reported: December 3, 2025 Initiated: October 17, 2025 #Z-0582-2026
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.
Details
- Recalling Firm
- Straumann USA LLC
- Units Affected
- 61 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;. Recalled by Straumann USA LLC. Units affected: 61 units.
Why was this product recalled? ▼
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Moderate. Recall number: Z-0582-2026.
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