BEUDAMED
    FDA Recall Terminated

    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.

    Recall: Z-2158-2012 · Initiated March 23, 2012

    Recall

    Recall Number
    Z-2158-2012
    Event Number
    62375
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 23, 2012
    Posted
    August 8, 2012
    Terminated
    December 16, 2013
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.

    Reason

    Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.

    Action

    BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return.

    Distribution

    Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.

    Quantity

    240