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FDA-Device2026-04-01Class IIPROCESSING DEFECT

Straumann Custom Abutment Ti recalled for incorrect material composition

Straumann
OTHERNationwide distribution

Stop using affected Straumann Custom Abutment Ti units

Straumann USA LLC recalled certain Custom Abutment Ti units (catalog number 027.4620) because of a manufacturing error. A raw material bar made of TAN material was mistakenly labeled and used instead of the correct Titanium Grade 4 material during production. This affects 13 units distributed in the US and Canada.

  • Contact your dental provider or Straumann USA LLC if you received one of the affected abutment units
  • Check the lot number on your abutment against the list provided by Straumann
  • Do not use affected units; ask your provider about replacement options
Hazard

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.

Sold states
Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
Affected count
13 units
Manufactured in
60 Minuteman Rd, Andover, MA, United States
Products
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1632-2026

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