Recall
FDAHealthMarch 27, 2026

Straumann USA LLC — Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

⚠️ Includes an incorrect screw seat interface.

Is this relevant to me?

Geography
US, AL, AZ, FL, HI, LA, MD, OH, VA
Source agency
FDA
Category
Health
Published
March 27, 2026

US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

What's affected?

Product
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Lot code
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.

Additional details

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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 6 units.

View original FDA notice →

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