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FDAMarch 17, 2026device

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

straumann

UPCs

07630031773937

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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