BEUDAMED
    FDA Enforcement Class II Ongoing

    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

    Recall: Z-2941-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2941-2024
    Event ID
    95077
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 4, 2024
    Initiation Date
    July 4, 2024
    Classification Date
    August 29, 2024
    Address
    1111 Chomedey (A-13) E, Laval, N/A, Canada

    Description

    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

    Reason

    During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

    Code Info

    Part Number FRT250; Lot Numbers: F281-04, F462-02

    Distribution

    Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.

    Quantity

    6 units