Class IIOngoingZ-1995-2026
Straumann USA LLC recalls Straumann n!ce Zr
Includes an incorrect screw seat interface.
Straumann USA LLCMAMay 6, 2026
Abutment, Implant, Dental, Endosseous recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 16 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 IIOngoingZ-0417-2026
Prismatik Dentalcraft, Inc. recalls Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3…
Incorrect titanium screw, packaged with dental implant.
Prismatik Dentalcraft,…CANov 12, 2025
Class IIOngoingZ-2514-2025
Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry;…
Preat CorpCASep 10, 2025
Class IIOngoingZ-2107-2025
Preat Corp recalls Preat
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Preat CorpCAJul 16, 2025
Class IIOngoingZ-1987-2025
Preat Corp recalls Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Ab…
Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
Preat CorpCAJun 25, 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-1276-2025
Hiossen Inc. recalls Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is inte…
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version;…
Hiossen Inc.PAMar 12, 2025
Class IIOngoingZ-1275-2025
Hiossen Inc. recalls ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant…
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version;…
Hiossen Inc.PAMar 12, 2025
Class IIOngoingZ-1274-2025
Hiossen Inc. recalls Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is inte…
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version;…
Hiossen Inc.PAMar 12, 2025