The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1632-2026·Announced 2026-04-01

Straumann custom abutments made from wrong bar material after mix-up

Straumann is recalling Custom Abutment Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: implanted dental abutments were made from a different alloy than specified, and no injuries are stated in the source.

Plain-English summary

Straumann USA LLC is recalling the Custom Abutment Ti for Straumann RC, including TAN screw, catalogue number 027.4620. About 13 units were distributed across ten US states and to Canada. The FDA has classified this recall as Class II.

A material mix-up occurred during the manufacturing of Straumann Custom Abutments. 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.

Affected product carries UDI-DI 07630031713766, across thirteen listed order numbers.

Facilities can identify affected abutments by the catalogue number, UDI and order numbers above, and may contact Straumann USA LLC for further information.

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 — Dental implant
Hazard
Affected units
13

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.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Straumann USA LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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