BEUDAMED
    FDA Recall Terminated

    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

    Recall: Z-1961-2013 · Initiated May 10, 2013

    Recall

    Recall Number
    Z-1961-2013
    Event Number
    65005
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 10, 2013
    Posted
    August 13, 2013
    Terminated
    August 13, 2014
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (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.

    Action

    The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.

    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

    33