Straumann USA LLC
9 federal recalls on file, showing the 4 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Straumann USA LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-01FDA-DeviceClass IICustom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
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.
- 2026-04-01FDA-DeviceClass IIStop using affected Straumann Custom Abutment Ti units
Straumann USA LLC recalled certain Custom Abutment Ti units (catalog number 027.4620) because of a manufacturing error. A raw material bar made of TAN material was mistakenly labeled and used instead of the correct Titanium Grade 4 material during production. This affects 13 units distributed in the US and Canada.
- 2026-02-18FDA-DeviceClass IIICheck your Straumann impression post kit
Straumann USA LLC recalled certain WB Impression Post Closed Tray kits because they contain magenta impression caps instead of the correct brown caps. This mix-up could lead to using the wrong component during dental implant procedures. The recall affects 561 units distributed nationwide.
- 2025-12-03FDA-DeviceClass IIEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
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