FDA DeviceApr 1, 2026Class II

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

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.

From the FDA notice · Read the official notice ↗ · All Straumann recalls

What to do

The agency's notice has the remedy and who to contact.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 7 units
Illnesses reported: None reported
Manufactured in: 60 Minuteman Rd, Andover, MA, United States
Classification: Class II
Recall number: Z-1633-2026

In the FDA's words

Description: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; 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. Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00; Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada. Affected quantity: 7 units
Hazard: 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.

2 products in this recall

Straumann custom abutments recalled for wrong raw material

Straumann is recalling two custom abutment products, 20 units in total, for dental implant use. A raw material bar of TAN material was mislabeled as titanium Grade 4, so some RC Titanium abutments were made from the wrong material. The affected units were distributed in several U.S. states and in Canada. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Z-1632-2026 · 13 units
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; (this page)
Z-1633-2026 · 7 units