Class IIOngoingZ-1995-2026
Straumann USA LLC recalls Straumann n!ce Zr
Includes an incorrect screw seat interface.
- Endosseous Dental Implant Abutment
- Under Investigation by firm
Straumann USA LLCMAMay 6, 2026
Straumann USA LLC recalls
The FDA has posted 11 enforcement recalls from Straumann USA LLC since 2025, none of them Class I (most serious). Most recent report: May 6, 2026.
Class II: 10Class III: 1
Latest recalls
View all 11 in the recall browser →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.
- Endosseous Dental Implant Abutment
- Under Investigation by firm
Straumann USA LLCMAMay 6, 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…
- Endosseous Dental Implant Abutment
- Process control
Straumann USA LLCMAApr 1, 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…
- Endosseous Dental Implant Abutment
- Process control
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.
- Endosseous Dental Implant Accessories
- Under Investigation by firm
Straumann USA LLCMAFeb 18, 2026
Class IIOngoingZ-0582-2026
Straumann USA LLC recalls Emdogain
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Dental Biologic Material
- Under Investigation by firm
Straumann USA LLCMADec 3, 2025
Class IIOngoingZ-1862-2025
Straumann USA LLC recalls GM Helix Acqua Implant
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Root-Form Endosseous Implant
- Under Investigation by firm
Straumann USA LLCMAJun 4, 2025
Class IIOngoingZ-1861-2025
Straumann USA LLC recalls Plus Initial Drill
The referred batch was produced without the laser engraving of 7 mm.
- Intraoral Dental Drill
- Under Investigation by firm
Straumann USA LLCMAJun 4, 2025
Class IIOngoingZ-1863-2025
Straumann USA LLC recalls GM Helix Acqua Implant
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Root-Form Endosseous Implant
- Under Investigation by firm
Straumann USA LLCMAJun 4, 2025
Class IIOngoingZ-1671-2025
Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
- Endosseous Dental Implant Abutment
- Under Investigation by firm
Straumann USA LLCMAApr 30, 2025
Class IIOngoingZ-1561-2025
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver
The devices are missing the laser marked depth markings.
- Endosseous Dental Implant Accessories
- Process control
Straumann USA LLCMAApr 23, 2025
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.