BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

    Recall: Z-1701-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1701-2017
    Event ID
    76809
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    March 8, 2017
    Classification Date
    March 29, 2017
    Termination Date
    August 2, 2019
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

    Reason

    A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier

    Code Info

    LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571

    Distribution

    Argentina

    Quantity

    5