Reported Apr 1, 2026 · Ongoing
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
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?
- Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 Catalog Number/Art.: 027.4620 2 07630031713766UDI-DI: 07630031713766 3 Order number (lot): 92465US_12039_00_b00 , 92465US_12040_00_b00 , 92465US_12047_00_b00 , 92465US_12048_00_b00 , 70959US_02227_00_b00 , 94021US_02348_00_b00, 70416US_07543_00_b00 , 91395US_01687_00_b00 , 91545US_03284_00_b00 , 91545US_03285_00_b00 , 71711US_00420_00_b00 , 91853US_06313_00_b00 , 72747US_00247_00_b00 - Amount recalled
- 13 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
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
This product could cause temporary or reversible health problems — stop using it.
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