Reported May 6, 2026 · Ongoing
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- Lot codes and dates
- Article 010.0158
- UDI(01)07630031759764(11)YYMMDD(10)XXXXX
- Project Numbers
28000US_00622_00_b0028000US_00431_00_b0028000US_00489_00_b0028000US_00792_00_b0028000US_00908_00_b0028000US_00908_01_b00
- Amount recalled
- 6 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Includes an incorrect screw seat interface.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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