BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

    Recall: Z-2073-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2073-2017
    Event ID
    77022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Microfixation, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 11, 2017
    Classification Date
    May 12, 2017
    Termination Date
    August 6, 2019
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480, United States

    Description

    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

    Reason

    Part of the number on the tray lid differ from the part number on the base.

    Code Info

    Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

    Distribution

    AL, MO and UT Canada, Australia, Netherlands, and Egypt

    Quantity

    33 units