Class IIReported 2025-12-03

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Recalled by Straumann USA LLC

Reason for Recall

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

Recall Number

Z-0582-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-10-17

Reported

2025-12-03

Distribution

US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.

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;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.