Recall Z-0582-2026 ยท NQA Biologic Material, Dental
Straumann USA LLC
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
| Date | Nov 21, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| Reason | The possibility for this product that is intended for demonstration purposes only to be placed in patients. |
| Root cause | Under Investigation by firm |
| Action | 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. Tra |
| Quantity | 61 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.