BEUDAMED
    FDA Recall Terminated

    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast

    Recall: Z-2884-2011 · Initiated March 14, 2011

    Recall

    Recall Number
    Z-2884-2011
    Event Number
    58921
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 14, 2011
    Posted
    July 26, 2011
    Terminated
    July 27, 2011
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast

    Reason

    Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was distributed in Europe only.

    Action

    Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers. The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification. For additional information, please contact Customer Service at 800-342-5454.

    Distribution

    Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL

    Quantity

    232 unit