Z-1632-2026
Class II · Ongoing
- Recalling firm
- Straumann USA LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 20260317
- Firm location
- Andover, MA, United States
Product description
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
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.