BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    Recall: Z-0593-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0593-2016
    Event ID
    72446
    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
    January 13, 2016
    Initiation Date
    September 21, 2015
    Classification Date
    January 5, 2016
    Termination Date
    October 12, 2016
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    Reason

    Inadequate biocompatibility testing.

    Code Info

    Model Number: PIC484, Lot Numbers: 942680, 950198, 950706, 957203, 963249, 973436, 977567, 993384, 1004520, 1015298, 1024240, 1034518, 1048991, 1057119, 1095480, 1105770, 1131300, 1133485, 1158650, 1165796, 1169295, 1172741, 1175519, 1178568, 1181589, 1184490; Model Number: PIC484H, Lot Numbers: 952664, 1023220, 1034517, 1057121, 1084058, 1085156, 1086404, 1115750, 1169297, 1174217, 1182906, 1187568; Model Number: PIC485, Lot Numbers: 1137568, 1137603, 1176653, 1184855; Model Number: PIC485H, Lot Numbers: 1113005, 1170171, 1181580; Model Number: PIC654, Lot Numbers: 934480, 950196, 954781, 957204, 961452, 977568, 988996, 1016258, 1024427, 1034516, 048990, 1060550, 1073328, 1073329, 1092256, 1105771, 1115811, 1115812, 1115813, 1115815, 1115816, 1116774; Model Number: PIC654H, Lot Numbers: 970700, 988995, 989022, 1015301, 1043973, 1069114, 1073325, 1073327, 1074848, 1147383, 1166591, 1174216, 1184508, 1184509; Model Number: PIC655, Lot Numbers: 1040760, 1044047, 1048195, 1115778; Model Number: PIC655H, Lot Numbers: 1031581, 1079916, 973403-S1.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.

    Quantity

    30,111 devices.