United StatesStraumann n!ce PMMA Full-arch Restoration screw‑retained bridge (Article 010.0304) and Straumann n!ce Zr, HT Full‑arch Restoration (Article 010.0158) endosseous dental implant abutments are affected; they can be identified by the article numbers, UDIs listed ((01)07630031779977… and (01)07630031759764…) and the project numbers provided. The devices were distributed in the US (AL, AZ, FL, HI, LA, MD, OH, VA). They were recalled because they include an incorrect screw seat interface.
What's being recalled
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Recalling firm: Straumann USA LLC, Andover, MA, United States.
How to identify it
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. Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00, 28000US_00431_00_b00, 28000US_00489_00_b00, 28000US_00792_00_b00, 28000US_00908_00_b00, 28000US_00908_01_b00.
The hazard
Includes an incorrect screw seat interface.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)