BEUDAMED
    FDA Enforcement Class II Ongoing

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

    Recall: Z-1320-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1320-2024
    Event ID
    94063
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    In2Bones, SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 27, 2024
    Initiation Date
    January 26, 2024
    Classification Date
    March 20, 2024
    Address
    28 Chemin du petit Bois, Ecully, N/A, France

    Description

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

    Reason

    This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

    Code Info

    UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028

    Distribution

    US Nationwide distribution in the state of Tennessee.

    Quantity

    63 units