FDA-Device2026-04-01Class II

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

Straumann USA LLC

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.

Sold states

Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.

Affected count

7 units

Manufactured in

60 Minuteman Rd, Andover, MA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2026

Original summary

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

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