The FDA has posted 13 enforcement recalls from Straumann USA LLC 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.…
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.
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.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
The referred batch was produced without the laser engraving of 7 mm.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Incorrect blister labelling.
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.