CLASS II · ModerateFDA

Straumann USA LLC recalls Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. End

📅 Mar 27, 2026 · 📍 AL, AZ, FL, HI, LA, MD, OH, VA

Recalling company: Straumann USA LLC
Product: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Reason: Includes an incorrect screw seat interface.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Mar 27, 2026
Reported: May 6, 2026
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Status: Ongoing
Quantity: 5 units
Lot / codes: 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.
Company location: Andover, MA
Recall type: Voluntary: Firm initiated
Recall number: Z-1994-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1994-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.