Recall Z-1633-2026— Straumann USA LLC

Name: FDA recall Z-1633-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2026-03-17. It names one FDA 510(k) clearance: K243278. Product: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;. Reason: 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..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K243278 — Custom AbutmentsInstitut Straumann AG·cleared 2025-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.