Straumann USA LLC device recall (Cls II)

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; — Reason: 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. — Status: Ongoing