Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
FDA Recall #Z-0582-2026 — Class II — October 17, 2025
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.
Recalling Firm
Straumann USA LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
61 units
Distribution
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated