FDA Medical devices recall ·
Straumann n!ce PMMA Full-arch Restoration recall
- Recall number
- Z-1994-2026
- Date
- (initiated March 27, 2026)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Why was it recalled?
Includes an incorrect screw seat interface.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alabama Arizona Florida Hawaii Louisiana Maryland Ohio Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1994-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.