Class IIOngoingZ-1995-2026
Straumann USA LLC recalls Straumann n!ce Zr
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Straumann USA LLC recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–11 of 11 recalls
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
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.
Straumann USA LLCMADec 3, 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.
Straumann USA LLCMAJun 4, 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.
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.
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.
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.
Straumann USA LLCMAApr 23, 2025