BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

    Recall: Z-1647-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1647-2020
    Event ID
    85153
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2020
    Initiation Date
    February 26, 2020
    Classification Date
    April 3, 2020
    Termination Date
    July 29, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

    Reason

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Code Info

    ***Lot Numbers*** 978860, 087790, 087800, 157940, 558560, 564460, 052410, 052420, 052430, 052470, 052480, 230620, 230650, 575290, 767190, 766930, 789110, 031190, 031210, 031320, 265710, 349900, 654570, 927670, 767300, 817690, 188780, 188790, 932920, 205930, 429810, 655510, 092640, 757250, 771000, 683180, 803570, 217230, 197360, 291810, 799130, 552560, 974130, 249280, 249290, 233870, 188790R, 547700, 116180, 071090, 071100, 116160, 784730, 946240, 767190R, 487340, 552590, 655510R, 431450, 617650, 617770, 736810, 988930, 934780, 920630, 092640R, 552560R, 799130R, 920630R, 233870R, 291810R. ***UDI Numbers*** (01)00880304521155(17)160628(10)978860, (01)00880304521155(17)160728(10)087790, (01)00880304521155(17)160728(10)087800, (01)00880304521155(17)160728(10)157940, (01)00880304521155(17)160831(10)558560, (01)00880304521155(17)160928(10)564460, (01)00880304521155(17)170228(10)052410, (01)00880304521155(17)170228(10)052420, (01)00880304521155(17)170228(10)052430, (01)00880304521155(17)170228(10)052470, (01)00880304521155(17)170228(10)052480, (01)00880304521155(17)180108(10)230620, (01)00880304521155(17)180108(10)230650, (01)00880304521155(17)180215(10)575290, (01)00880304521155(17)180307(10)767190, (01)00880304521155(17)180330(10)766930, (01)00880304521155(17)180313(10)789110, (01)00880304521155(17)180430(10)031190, (01)00880304521155(17)180405(10)031210, (01)00880304521155(17)180405(10)031320, (01)00880304521155(17)181101(10)265710, (01)00880304521155(17)190101(10)349900, (01)00880304521155(17)190731(10)654570, (01)00880304521155(17)190807(10)927670, (01)00880304521155(17)190814(10)767300, (01)00880304521155(17)190813(10)817690, (01)00880304521155(17)191202(10)188780, (01)00880304521155(17)191204(10)188790, (01)00880304521155(17)200511(10)932920, (01)00880304521155(17)200609(10)205930, (01)00880304521155(17)200722(10)429810, (01)00880304521155(17)200805(10)655510, (01)00880304521155(17)201019(10)092640, (01)00880304521155(17)201109(10)757250, (01)00880304521155(17)201208(10)771000, (01)00880304521155(17)210215(10)683180, (01)00880304521155(17)210222(10)803570, (01)00880304521155(17)210321(10)217230, (01)00880304521155(17)210330(10)197360, (01)00880304521155(17)210616(10)291810, (01)00880304521155(17)210831(10)799130, (01)00880304521155(17)211105(10)552560, (01)00880304521155(17)220629(10)974130, (01)00880304521155(17)220518(10)249280, (01)00880304521155(17)220524(10)249290, (01)00880304521155(17)220726(10)233870, (01)00880304521155(17)191204(10)188790R, (01)00880304521155(17)221211(10)547700, (01)00880304521155(17)221219(10)116180, (01)00880304521155(17)221229(10)071090, (01)00880304521155(17)230109(10)071100, (01)00880304521155(17)221229(10)116160, (01)00880304521155(17)221227(10)784730, (01)00880304521155(17)230115(10)946240, (01)00880304521155(17)180307(10)767190R, (01)00880304521155(17)230320(10)487340, (01)00880304521155(17)230321(10)552590, (01)00880304521155(17)200805(10)655510R, (01)00880304521155(17)230321(10)431450, (01)00880304521155(17)230328(10)617650, (01)00880304521155(17)230416(10)617770, (01)00880304521155(17)230415(10)736810, (01)00880304521155(17)230412(10)988930, (01)00880304521155(17)230507(10)934780, (01)00880304521155(17)230511(10)920630, (01)00880304521155(17)201019(10)092640R, (01)00880304521155(17)211105(10)552560R, (01)00880304521155(17)210831(10)799130R, (01)00880304521155(17)230511(10)920630R, (01)00880304521155(17)220726(10)233870R, (01)00880304521155(17)210616(10)291810R

    Distribution

    Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

    Quantity

    230,001