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, 11 X 200 MM, Silicone, Sterile, Item 431196.

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*** 188860, 326860, 558630, 628180, 977670, 116350, 122520, 437230, 437290, 740330, 341070, 576690, 789080, 063540, 555070, 916280, 167510, 200790, 388910, 551820, 408270, 135820, 359260, 726800, 589000, 739960, 056940, 188810, 846790, 043650, 061850, 356930, 817130, 817180, 374980, 655520, 655530, 655540, 940150, 205910, 745770, 771020, 771030, 030880, 774440, 803790, 997470, 997500, 336220, 291950, 130830, 396920, 396930, 564620, 777740, 323510, 633930, 633940, 655650, 817180R, 548570, 946280, 116220, 438820, 453240, 224260, 438760, 453250, 916090, 916100, 946330, 295870, 431490, 070870, 070880, 438790, 388350, 548590, 737050, 275360, 359630, 712130, 034750, 275350, 737040, 950390, 974350, 989000, 042720, 144790, 179610, 478530, 478580, 478590, 639710, 639720, 639730, 639740, 639770, 639700, 262090, 262110, 404030, 404070, 717660, 717670, 717700, 717710, 717720, 717730, 717740, 717750, 777660, 845560, 877570, 037590, 063850, 210780, 789020, 717680, 789010, 029280, 073240, 807470, 807480, 807490, 807510, 807520, 894620, 330980, 465430, 548590R, 554680, 554690, 585440, 673800, 673820, 723570, 758520, 865920, 885460, 810970, 865910, 885430, 924720, 034970, 885440, 924690, 924700, 946970, 946980. ***UDI Numbers*** (01)00880304521117(17)160128(10)188860, (01)00880304521117(17)160728(10)326860, (01)00880304521117(17)160828(10)558630, (01)00880304521117(17)160928(10)628180, (01)00880304521117(17)161128(10)977670, (01)00880304521117(17)170728(10)116350, (01)00880304521117(17)170728(10)122520, (01)00880304521117(17)171028(10)437230, (01)00880304521117(17)171028(10)437290, (01)00880304521117(17)171128(10)740330, (01)00880304521117(17)180128(10)341070, (01)00880304521117(17)180219(10)576690, (01)00880304521117(17)180307(10)789080, (01)00880304521117(17)180410(10)063540, (01)00880304521117(17)180619(10)555070, (01)00880304521117(17)180831(10)916280, (01)00880304521117(17)180820(10)167510, (01)00880304521117(17)180903(10)200790, 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(01)00880304521117(17)201210(10)030880, (01)00880304521117(17)210218(10)774440, (01)00880304521117(17)210219(10)803790, (01)00880304521117(17)210303(10)997470, (01)00880304521117(17)210303(10)997500, (01)00880304521117(17)210330(10)336220, (01)00880304521117(17)210714(10)291950, (01)00880304521117(17)210824(10)130830, (01)00880304521117(17)210916(10)396920, (01)00880304521117(17)210927(10)396930, (01)00880304521117(17)211104(10)564620, (01)00880304521117(17)220329(10)777740, (01)00880304521117(17)220605(10)323510, (01)00880304521117(17)220612(10)633930, (01)00880304521117(17)220612(10)633940, (01)00880304521117(17)220612(10)655650, (01)00880304521117(17)200518(10)817180R, (01)00880304521117(17)221211(10)548570, (01)00880304521117(17)221208(10)946280, (01)00880304521117(17)221218(10)116220, (01)00880304521117(17)221216(10)438820, (01)00880304521117(17)221121(10)453240, (01)00880304521117(17)221231(10)224260, (01)00880304521117(17)221231(10)438760, (01)00880304521117(17)221231(10)453250, (01)00880304521117(17)230106(10)916090, (01)00880304521117(17)230106(10)916100, (01)00880304521117(17)221229(10)946330, (01)00880304521117(17)230114(10)295870, (01)00880304521117(17)230116(10)431490, (01)00880304521117(17)230118(10)070870, (01)00880304521117(17)230118(10)070880, (01)00880304521117(17)230124(10)438790, (01)00880304521117(17)230128(10)388350, (01)00880304521117(17)230201(10)548590, (01)00880304521117(17)230306(10)737050, (01)00880304521117(17)230411(10)275360, (01)00880304521117(17)230411(10)359630, (01)00880304521117(17)230411(10)712130, (01)00880304521117(17)230416(10)034750, (01)00880304521117(17)230411(10)275350, (01)00880304521117(17)230417(10)737040, (01)00880304521117(17)230417(10)950390, (01)00880304521117(17)230417(10)974350, (01)00880304521117(17)230411(10)989000, (01)00880304521117(17)230508(10)042720, (01)00880304521117(17)230511(10)144790, (01)00880304521117(17)230513(10)179610, (01)00880304521117(17)240510(10)478530, (01)00880304521117(17)240510(10)478580, (01)00880304521117(17)240512(10)478590, (01)00880304521117(17)240511(10)639710, (01)00880304521117(17)240514(10)639720, (01)00880304521117(17)240512(10)639730, (01)00880304521117(17)240513(10)639740, (01)00880304521117(17)240514(10)639770, (01)00880304521117(17)240515(10)639700, (01)00880304521117(17)240607(10)262090, (01)00880304521117(17)240529(10)262110 (01)00880304521117(17)240716(10)404030, (01)00880304521117(17)240716(10)404070, (01)00880304521117(17)240608(10)717660, (01)00880304521117(17)240612(10)717670, (01)00880304521117(17)240613(10)717700, (01)00880304521117(17)240611(10)717710, (01)00880304521117(17)240612(10)717720, (01)00880304521117(17)240612(10)717730, (01)00880304521117(17)240611(10)717740, (01)00880304521117(17)240611(10)717750, (01)00880304521117(17)240611(10)777660, (01)00880304521117(17)240616(10)845560, (01)00880304521117(17)240617(10)877570, (01)00880304521117(17)240819(10)037590, (01)00880304521117(17)240831(10)063850, (01)00880304521117(17)240829(10)210780, (01)00880304521117(17)240926(10)789020, (01)00880304521117(17)241003(10)717680, (01)00880304521117(17)241009(10)789010, (01)00880304521117(17)241011(10)029280, (01)00880304521117(17)241010(10)073240, (01)00880304521117(17)241009(10)807470, (01)00880304521117(17)241009(10)807480, (01)00880304521117(17)241009(10)807490, (01)00880304521117(17)241009(10)807510, (01)00880304521117(17)241009(10)807520, (01)00880304521117(17)241009(10)894620, (01)00880304521117(17)241023(10)330980, (01)00880304521117(17)241105(10)465430, (01)00880304521117(17)230201(10)548590R, (01)00880304521117(17)241118(10)554680, (01)00880304521117(17)241118(10)554690, (01)00880304521117(17)241118(10)585440, (01)00880304521117(17)241204(10)673800, (01)00880304521117(17)241204(10)673820, (01)00880304521117(17)241205(10)723570, (01)00880304521117(17)241206(10)758520, (01)00880304521117(17)241218(10)865920, (01)00880304521117(17)241218(10)885460, (01)00880304521117(17)250103(10)810970, (01)00880304521117(17)250110(10)865910, (01)00880304521117(17)250110(10)885430, (01)00880304521117(17)250110(10)924720, (01)00880304521117(17)250124(10)034970, (01)00880304521117(17)250123(10)885440, (01)00880304521117(17)250128(10)924690, (01)00880304521117(17)250123(10)924700, (01)00880304521117(17)250123(10)946970, (01)00880304521117(17)250124(10)946980
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