BEUDAMED
    FDA Enforcement Class II Terminated

    In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

    Recall: Z-1283-2021 · Reported March 31, 2021

    Enforcement

    Recall Number
    Z-1283-2021
    Event ID
    87341
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2Bones, SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 31, 2021
    Initiation Date
    February 9, 2021
    Classification Date
    March 19, 2021
    Termination Date
    July 11, 2024
    Address
    28 Chemin du petit Bois, N/A, Ecully, N/A, N/A, France

    Description

    In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

    Reason

    This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

    Code Info

    Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062

    Distribution

    US Nationwide distribution in the state of TN.

    Quantity

    60 units