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

FDA device recall Z-0582-2026 · posted 2025-11-21 · Open, Classified

Recall details

Recalling firm

Straumann USA LLC

Reason for recall

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

Action taken

On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NQA

Quantity affected

61 units

Distribution

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

Date initiated

2025-10-17

Date posted

2025-11-21

Location

Andover, MA