BEUDAMED
    FDA Enforcement Class II Terminated

    OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

    Recall: Z-1410-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1410-2015
    Event ID
    70628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 22, 2015
    Initiation Date
    November 7, 2014
    Classification Date
    April 10, 2015
    Termination Date
    May 22, 2015
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

    Reason

    Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

    Code Info

    Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

    Quantity

    620 implants in total