BEUDAMED
    FDA Enforcement Class II Terminated

    Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.

    Recall: Z-0379-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0379-2019
    Event ID
    81161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AROA BIOSURGERY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2018
    Initiation Date
    November 27, 2018
    Classification Date
    November 2, 2018
    Termination Date
    April 9, 2019
    Address
    2 Kingsford Smith Place, Airport Oaks, N/A, New Zealand

    Description

    Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.

    Reason

    Potential for pouch seal failure

    Code Info

    Lot numbers: EDT-7I02 EDT-7L02

    Distribution

    US Nationwide Distribution

    Quantity

    8,853 total boxes