medical Class II Updated 2020-04-15

Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinfo

Recalled Product

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

Hazard / Issue

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

Issued by

FDA

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.
Lot/Code Info: ***Lot Numbers*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 474150, 576700, 110750, 672080, 143910, 713260, 359270, 529160, 160630, 301450, 188850, 188840, 886920, 066020, 364260, 077620, 077630, 429820, 492480, 661200, 092850, 771050, 997420, 997410, 291970, 291870, 799190, 397000, 564140, 564130, 997410R, 809850, 809870, 809910, 224890, 548620, 809890, 916180, 070370, 224900, 224940, 224950, 164220, 164270, 164320, 224930, 295910, 388560, 388610, 388630, 552720, 552740, 388620, 552730, 737160, 875440, 989030, 291870R, 359270R, 799190R, 275380, 035010, 950420, 042970, 179530, 388620R, 717600, 717630, 777730, 356080, 717610, 717640, 777680, 777720, 864800, 864810, 864820, 864830, 879760, 063880, 164320R, 809910R, 224930R, 777710, 580090, 789080, 807580, 029320, 807550, 807560, 807590, 717620, 073260, 073270, 364280, 364300, 488070, 525680, 554710, 641750, 641840, 673840, 770190, 835130, 885470, 947000. ***UDI Numbers*** 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(01)00880304521131(17)200505(10)364260, (01)00880304521131(17)200608(10)077620, (01)00880304521131(17)200609(10)077630, (01)00880304521131(17)200710(10)429820, (01)00880304521131(17)200727(10)492480, (01)00880304521131(17)200728(10)661200, (01)00880304521131(17)201001(10)092850, (01)00880304521131(17)201117(10)771050, (01)00880304521131(17)210228(10)997420, (01)00880304521131(17)210303(10)997410, (01)00880304521131(17)210706(10)291970, (01)00880304521131(17)210713(10)291870, (01)00880304521131(17)210830(10)799190, (01)00880304521131(17)210912(10)397000, (01)00880304521131(17)211102(10)564140, (01)00880304521131(17)220420(10)564130, (01)00880304521131(17)210303(10)997410R, (01)00880304521131(17)221203(10)809850, (01)00880304521131(17)221214(10)809870, (01)00880304521131(17)221218(10)809910, (01)00880304521131(17)230109(10)224890, (01)00880304521131(17)221231(10)548620, (01)00880304521131(17)221228(10)809890, (01)00880304521131(17)221231(10)916180, (01)00880304521131(17)230115(10)070370, 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(01)00880304521131(17)230507(10)042970, (01)00880304521131(17)230510(10)179530, (01)00880304521131(17)230128(10)388620R, (01)00880304521131(17)240527(10)717600, (01)00880304521131(17)240527(10)717630, (01)00880304521131(17)240527(10)777730, (01)00880304521131(17)240608(10)356080, (01)00880304521131(17)240528(10)717610, (01)00880304521131(17)240611(10)717640, (01)00880304521131(17)240805(10)777680, (01)00880304521131(17)240619(10)777720, (01)00880304521131(17)240615(10)864800, (01)00880304521131(17)240617(10)864810, (01)00880304521131(17)240626(10)864820, (01)00880304521131(17)240615(10)864830, (01)00880304521131(17)240813(10)879760, (01)00880304521131(17)240828(10)063880, (01)00880304521131(17)230115(10)164320R, (01)00880304521131(17)221218(10)809910R, (01)00880304521131(17)230118(10)224930R, (01)00880304521131(17)240912(10)777710, (01)00880304521131(17)240926(10)580090, (01)00880304521131(17)240926(10)789080, (01)00880304521131(17)241008(10)807580, (01)00880304521131(17)241011(10)029320, (01)00880304521131(17)241009(10)807550, (01)00880304521131(17)241010(10)807560, (01)00880304521131(17)241009(10)807590, (01)00880304521131(17)241018(10)717620, (01)00880304521131(17)241023(10)073260, (01)00880304521131(17)241023(10)073270, (01)00880304521131(17)241023(10)364280, (01)00880304521131(17)241023(10)364300, (01)00880304521131(17)241106(10)488070, (01)00880304521131(17)241106(10)525680, (01)00880304521131(17)241119(10)554710, (01)00880304521131(17)241119(10)641750, (01)00880304521131(17)241119(10)641840, (01)00880304521131(17)241205(10)673840, (01)00880304521131(17)250102(10)770190, (01)00880304521131(17)250105(10)835130, (01)00880304521131(17)250102(10)885470, (01)00880304521131(17)250128(10)947000
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