BEUDAMED
    FDA Enforcement Class II Terminated

    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.

    Recall: Z-1478-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1478-2017
    Event ID
    76638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inion Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 22, 2017
    Initiation Date
    March 1, 2017
    Classification Date
    March 16, 2017
    Termination Date
    December 18, 2017
    Address
    Laakarinkatu 2, N/A, FIN-33520 Tampere, N/A, N/A, Finland

    Description

    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.

    Reason

    Aluminum pouch seal was noticed to be defective (slightly open).

    Code Info

    Lot Number 1604006, 1505007, 1503039

    Distribution

    US Distribution to : FL and NC.

    Quantity

    36 pieces