BEUDAMED
    FDA Recall Terminated

    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

    Recall: Z-0432-2019 · Initiated April 6, 2018

    Recall

    Recall Number
    Z-0432-2019
    Event Number
    81166
    Firm
    AROA Biosurgery, LTD.
    FEI Number
    3007321028
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2018
    Terminated
    April 15, 2019
    Address
    69 Gracefield Road, Lower Hutt New Zealand

    Description

    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

    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.

    Action

    Beginning in April 2018, customers were visited by representatives and the affected units were replaced.

    Distribution

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

    Quantity

    881 total