BEUDAMED
    FDA Recall Open, Classified

    Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

    Recall: Z-0920-2025 · Initiated September 1, 2024

    Recall

    Recall Number
    Z-0920-2025
    Event Number
    95983
    Firm
    SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva
    FEI Number
    3004201263
    Product Code
    DZE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 1, 2024
    Posted
    January 15, 2025
    Address
    421 Sao Paulo Brazil

    Description

    Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

    Reason

    Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.

    Action

    On 9/1/2024, "URGENT: MEDICAL DEVICE RECALL" notices were emailed to customers and distributors who were told the following: The product should not be used. It does not pose a handling risk and should be separated and discarded. Complete and return the Medical Device Recall Return Response Acknowledgement and Receipt Form via email to: [email protected]. Customer with questions may contact the company via telephone at 0800-770-8290 between the hours of 9 and 19 (Brasilia time) or email the firm at [email protected].

    Distribution

    US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.

    Quantity

    123 (US 98, OUS 25)