Recalls / —
—#216511
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- FDA product code
- NQA — Biologic Material, Dental
- Device class
- Class 3
- Medical specialty
- Dental
- PMA numbers
- P930021
- Affected lot / 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;
Why it was recalled
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Straumann USA LLC
- Address
- 60 Minuteman Rd, Andover, Massachusetts 01810-1008
Distribution
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Timeline
- Recall initiated
- 2025-10-17
- Posted by FDA
- 2025-11-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #216511. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.