The FDA has posted 8 enforcement recalls from Straumann USA LLC since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
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…
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Firm name as filed with the FDA: “Straumann USA LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.