FDA-Device2026-04-01Class IIPROCESSING DEFECT
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
OTHERNationwide distribution
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.
Sold states
Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
Affected count
7 units
Manufactured in
60 Minuteman Rd, Andover, MA, United States
Products
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2026More Straumann USA LLC recalls
- FDA-Device2026-04-01Straumann Custom Abutment Ti recalled for incorrect material composition
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