Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1632-2026 — Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

U.S. FDA — Device Enforcement · United States · 2026-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1632-2026
Date of alert
2026-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Straumann USA LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07630031713766
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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