FDA-Device2026-04-01Class IIPROCESSING DEFECT

Straumann Custom Abutment Ti recalled for incorrect material composition

OTHERNationwide distributionMedical devices

What this means

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

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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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