BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

    Recall: Z-0852-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0852-2017
    Event ID
    75761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2016
    Initiation Date
    September 14, 2016
    Classification Date
    December 20, 2016
    Termination Date
    July 26, 2019
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

    Reason

    A limited number of product pouches may not have been sealed during packaging.

    Code Info

    Part # LPC443 Lot # 201611726

    Distribution

    Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

    Quantity

    50