BEUDAMED
    FDA Enforcement Class II Terminated

    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

    Recall: Z-2879-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2879-2018
    Event ID
    80618
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2bones USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    July 16, 2018
    Classification Date
    August 21, 2018
    Termination Date
    February 22, 2019
    Address
    Attn: Tommy Turpin, 6060 Poplar Ave Ste 380, Memphis, TN, 38119-3980, United States

    Description

    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

    Reason

    CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.

    Code Info

    Lot Number 1704073

    Distribution

    Worldwide Distribution - US Nationwide and the countries of France

    Quantity

    47 units