BEUDAMED
    FDA Enforcement Class II Terminated

    NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

    Recall: Z-0670-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0670-2019
    Event ID
    81655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2bones USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 14, 2018
    Classification Date
    December 22, 2018
    Termination Date
    May 8, 2019
    Address
    6060 Poplar Ave Ste 380, Memphis, TN, 38119-3915, United States

    Description

    NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

    Reason

    The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

    Code Info

    Lot Number: 9G88C0

    Distribution

    TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA

    Quantity

    30 units