FDAHealthMarch 27, 2026
Straumann USA LLC — Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
⚠️ Includes an incorrect screw seat interface.
Is this relevant to me?
- Geography
- US, AL, AZ, FL, HI, LA, MD, OH, VA
- Source agency
- FDA
- Category
- Health
- Published
- March 27, 2026
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
What's affected?
- Product
- Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
- Brand
- Straumann USA LLC
- Lot code
- 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.
Additional details
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 should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.