BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1633-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1633-2026
    Event ID
    98565
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2026
    Initiation Date
    March 17, 2026
    Classification Date
    March 24, 2026
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

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

    Reason

    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.

    Code Info

    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.

    Quantity

    7 units