BEUDAMED
    FDA Enforcement Class II Terminated

    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G

    Recall: Z-0431-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0431-2019
    Event ID
    81166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AROA Biosurgery, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 21, 2018
    Initiation Date
    April 6, 2018
    Classification Date
    November 9, 2018
    Termination Date
    April 15, 2019
    Address
    69 Gracefield Road, Lower Hutt, N/A, New Zealand

    Description

    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G

    Reason

    Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.

    Code Info

    ERT-6E14 ERT-6E17 ERT-8A02

    Distribution

    The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.

    Quantity

    881 total