Dental Implant Abutments Recall: Straumann n!ce Zr
Announced 2026-05-06 · FDA
The recall covers two Straumann Endosseous Dental Implant Abutments (Article Numbers 440.230V10 and 475.132V10) with multiple lot numbers (EPZM8, HPT6, KEWN9, NAAM6, VAW80, CRL56, HPHJ1). The product was intended for demonstration purposes only but could have been placed in patients. About 61 units were distributed nationwide in AZ, CA, DE, FL, ID, MO, TN, TX, UT, and VA.
| Brand | Straumann USA LLC |
|---|---|
| Product | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; |
| Reason | The possibility for this product that is intended for demonstration purposes only to be placed in patients. |
| Severity | moderate |
| Units affected | 6 |
| Distribution | US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA. |
| Agency | FDA |
| Recall / campaign no. | 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; |
WHAT YOU SHOULD DO
- If you have any of the recalled units, stop using them.
- Contact Straumann USA LLC or your dental professional for instructions on return or replacement.
- Provide article numbers and lot numbers to verify eligibility for recall and follow clinician guidance.
Other Straumann USA LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.