BEUDAMED
    FDA Enforcement Class II Terminated

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    Recall: Z-2780-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2780-2017
    Event ID
    77490
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    April 19, 2017
    Classification Date
    July 28, 2017
    Termination Date
    March 19, 2019
    Address
    330 Franklin Tpke, N/A, Mahwah, NJ, 07430-3524, United States

    Description

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    Reason

    There is a material mislabeling of the AFN End Cap.

    Code Info

    Item Code OS331107 S1009023 Mar-2017 S1009023 Mar-2017 Item Code OS331104 S1009020 Apr-2017 Item Code OS331100 995035 Aug-2017; Jan-2018 Item Code OS331100 S1212114 May-2018 Item Code OS331101 S1009017 Jun-2018 Item Code OS331103 S1009019 Oct-2018 Item Code OS331105 S1102004 Oct-2018 Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019 Item Code OS331103 S1009019 May-2019 Item Code OS331105 S1102004 May-2019 Item Code OOS331100 7802 Oct-2019

    Distribution

    US distribution to MD, NY & PA

    Quantity

    277 units