BEUDAMED
    FDA Recall Terminated

    INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

    Recall: Z-0078-2019 · Initiated August 29, 2018

    Recall

    Recall Number
    Z-0078-2019
    Event Number
    81008
    Firm
    Incisive Surgical Inc
    FEI Number
    3004028675
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 29, 2018
    Terminated
    March 18, 2019
    Address
    14405 21st Ave N, Ste 130, Plymouth, MN, 55447-4638

    Description

    INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

    Reason

    Possible compromise of the sterile barrier integrity

    Action

    The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.

    Distribution

    Israel

    Quantity

    1200 units