Class IIOngoingZ-3173-2026
Straumann USA LLC recalls GM Helix Implant
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Straumann USA LLCMASep 23, 2026
Straumann USA LLC recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–8 of 8 recalls
Class IIOngoingZ-2935-2026
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant
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.
Straumann USA LLCMAAug 19, 2026
Class IIOngoingZ-2929-2026
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.…
Straumann USA LLCMAAug 19, 2026
Class IIOngoingZ-1995-2026
Straumann USA LLC recalls Straumann n!ce Zr
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Class IIOngoingZ-1994-2026
Straumann USA LLC recalls Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.…
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Class IIOngoingZ-1633-2026
Straumann USA LLC recalls Custom Abutment AS Ti
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…
Straumann USA LLCMAApr 1, 2026
Class IIOngoingZ-1632-2026
Straumann USA LLC recalls Custom Abutment Ti
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…
Straumann USA LLCMAApr 1, 2026
Class IIIOngoingZ-1337-2026
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Straumann USA LLCMAFeb 18, 2026