Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. ... recall (Straumann USA LLC)
Medical deviceClass IIOngoing
Summary: Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments. Reason: Includes an incorrect screw seat interface.
What is being recalled
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Why
Includes an incorrect screw seat interface.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. (states named: Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, Virginia)
How to tell if yours is affected
Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1994-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 27, 2026 |
| Reported | May 6, 2026 |
| Company | Straumann USA LLC |
| Company location | Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5 units |
More recalls from Straumann USA LLC · all medical device recalls · recalls from March 2026