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RecallWatchMedical Device Safety
Device type

Endosseous Dental Implant Abutment recalls

The FDA has posted 5 enforcement recalls of endosseous dental implant abutment devices since 2025, none of them Class I (most serious). Most recent report: Aug 19, 2026.

Class II: 5

Who is recalling these devices

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.…

  • Endosseous Dental Implant Abutment
  • Under Investigation by firm
Straumann USA LLCMAAug 19, 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

Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Abutment, Implant, Dental, Endosseous”). Informational only — verify against the FDA before acting.