BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1283-2021 · Initiated February 9, 2021

    Recall

    Recall Number
    Z-1283-2021
    Event Number
    87341
    Firm
    In2Bones, SAS 28 Chemin du petit Bois Ecully France
    FEI Number
    3010470577
    Product Code
    GFF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 9, 2021
    Terminated
    July 11, 2024

    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.

    Action

    A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.

    Distribution

    US Nationwide distribution in the state of TN.

    Quantity

    60 units