Z-1994-2026 Class II Ongoing
FDA device recall Z-1994-2026 was initiated by Straumann USA LLC on March 27, 2026 and is designated Class II. Reason for recall: Includes an incorrect screw seat interface. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Reason for Recall
Includes an incorrect screw seat interface.
Distribution Pattern
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Code Information
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.