FDA recall Z-0582-2026

Straumann USA LLC · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-17
Report date
2025-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2026