Straumann USA LLC
9 federal recalls on file. 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 IICustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
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.
- 2026-02-18FDA-DeviceClass IIIWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- 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.
- 2025-06-04FDA-DeviceClass IIGM Helix Acqua Implant, Article Number: 140.985
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceClass IIGM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceClass IIPlus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
- 2025-04-30FDA-DeviceClass IIWB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
- 2025-04-23FDA-DeviceClass IITLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
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