BEUDAMED
    FDA Recall Terminated

    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

    Recall: Z-2142-2019 · Initiated February 26, 2019

    Recall

    Recall Number
    Z-2142-2019
    Event Number
    82263
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2019
    Terminated
    June 15, 2020
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

    Reason

    During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

    Action

    The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.

    Distribution

    Nationwide and Puerto Rico, Canada, and Australia

    Quantity

    6 units