FDA Enforcement
Class II
Ongoing
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Recall: Z-1994-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-1994-2026
- Event ID
- 98681
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 6, 2026
- Initiation Date
- March 27, 2026
- Classification Date
- April 29, 2026
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008, United States
Description
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Reason
Includes an incorrect screw seat interface.
Code Info
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.
Distribution
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Quantity
5 units