Straumann USA LLC recalls GM Helix Implant
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.…
- Endosseous Dental Implant Abutment
- Under Investigation by firm
The FDA has posted 5 enforcement recalls of endosseous dental implant abutment devices since 2025, none of them Class I (most serious). Most recent report: Aug 19, 2026.
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.…
Includes an incorrect screw seat interface.
Includes an incorrect screw seat interface.
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 Gr…
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 Gr…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Abutment, Implant, Dental, Endosseous”). Informational only — verify against the FDA before acting.