The Recall Desk
HighFDA (Devices)·Z-1632-2026·Announced 2026-04-01

[pending] Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Pending LLM rewrite. Source: FDA_DEVICE Z-1632-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Manufacturer
Straumann USA LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Catalog Number/Art.: 027.4620
  • UDI-DI: 07630031713766
  • Order number (lot): 92465US_12039_00_b00
  • 92465US_12040_00_b00
  • 92465US_12047_00_b00
  • 92465US_12048_00_b00
  • 70959US_02227_00_b00
  • 94021US_02348_00_b00
  • 70416US_07543_00_b00
  • 91395US_01687_00_b00
  • 91545US_03284_00_b00
  • 91545US_03285_00_b00
  • 71711US_00420_00_b00
  • 91853US_06313_00_b00
  • 72747US_00247_00_b00

Distribution

Distributed nationwide across the United States.

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