BEUDAMED
    FDA Recall Terminated

    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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-0841-2017 · Initiated September 14, 2016

    Recall

    Recall Number
    Z-0841-2017
    Event Number
    75761
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 14, 2016
    Terminated
    July 26, 2019
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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.

    Action

    BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members. " All dentists and health care professionals will be notified via courier: - Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control. - Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted for using the form provided in the letter. - Dentists and health care professionals will complete and return the Inventory Return Certification Form to the fax number or email address provided. International distributors will be notified via email. Further distribution of the international customer notices will be sent through the local and regional distributors following local language translation. Communications will occur as translations are completed and are anticipated to occur during the week of September 12, 2016.1233. Customers with questions were instructed to call the customer call center at +44 (0) 800 652-1233.

    Distribution

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

    Quantity

    525