BEUDAMED
    FDA Enforcement Class II Terminated

    INFUSE Bone Graft X SMALL KIT REF 7510100

    Recall: Z-0440-2019 · Reported November 21, 2018

    Research enforcement Z-0440-2019 in seconds

    The Research Assistant summarizes enforcement actions and related recalls — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Enforcement

    Recall Number
    Z-0440-2019
    Event ID
    81171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    September 27, 2018
    Classification Date
    November 9, 2018
    Termination Date
    September 16, 2020
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    Description

    INFUSE Bone Graft X SMALL KIT REF 7510100

    Reason

    The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

    Code Info

    UDI 00613994239525, Lot Number M111806AAA

    Distribution

    US

    Quantity

    138 units