FDA Enforcement
Class II
Ongoing
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Recall: Z-0582-2026
·
Reported December 3, 2025
Enforcement
- Recall Number
- Z-0582-2026
- Event ID
- 97753
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 3, 2025
- Initiation Date
- October 17, 2025
- Classification Date
- November 21, 2025
- Address
- 60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States
Description
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.
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;
Distribution
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Quantity
61 units