Straumann N!Ce Full-Arch Restorations
Straumann n!ce PMMA Full-arch Restoration has an incorrect screw seat interface.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Straumann USA LLC of Andover, Massachusetts, recalled certain Straumann n!ce Zr and Straumann n!ce PMMA Full-arch Restorations because they include an incorrect screw seat interface. The FDA listed the recall in its enforcement report on April 29, 2026, after the company began the recall on March 27, 2026. The affected products were distributed to Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio and Virginia.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- UDI-DI
- 07630031759764
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
- UDI-DI
- 07630031779977
Details
- Company began the recall
- Event ID
- 98681
- Recall numbers
- Z-1994-2026 to Z-1995-2026
- Company
- Straumann USA LLCAndover, Massachusetts
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
