BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

    Recall: Z-1960-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1960-2013
    Event ID
    65005
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    May 10, 2013
    Classification Date
    August 13, 2013
    Termination Date
    August 13, 2014
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

    Reason

    A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.

    Code Info

    Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510

    Distribution

    Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.

    Quantity

    51