Straumann USA LLC Recalls
14 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (14)
- Class II
August 12, 2026
GM Helix Implant, REF: 109.984;
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Class II
July 16, 2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
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.
- Class II
July 13, 2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
- Class II
March 27, 2026
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Includes an incorrect screw seat interface.
- Class II
March 27, 2026
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Includes an incorrect screw seat interface.
- Class II
March 17, 2026
Custom 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.
- Class II
March 17, 2026
Custom 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.
- Class III
January 6, 2026
WB 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.
- Class II
October 17, 2025
Emdogain; 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.
- Class II
May 1, 2025
GM 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.
- Class II
May 1, 2025
GM 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.
- Class II
April 17, 2025
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
- Class II
April 14, 2025
Plus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
- Class II
March 8, 2025
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.