medical Class II Updated 2020-04-15

Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X

Recalled Product

BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

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*** 860710, 215430, 555230, 583850, 089660, 283370, 132850, 372710, 372760, 181880, 357230, 409110, 409190, 765360, 196690, 196700, 196710, 338960, 511930, 549800, 706840, 386790, 445290, 723200, 024040, 079210, 262220, 262230, 429560, 821040, 821050, 960990, 039770, 399430, 429450, 583060, 776890, 938560, 245080, 245090, 303380, 443600, 892230, 751870, 115420, 186520, 326920, 513020, 665290, 978020, 225130, 424200, 572910, 698790, 932210, 637420, 637430, 637440, 398110, 398120, 398140, 398150, 398160, 789690, 789700, 789670, 877260, 202510, 583060R, 572910R, 877260R, 398160R, 202500, 809040, 747440, 916120, 916130, 916140, 916150, 549800R, 349510, 349530, 349520, 710630, 710610, 846580, 846670, 846740, 895240, 915400, 963760, 996210, 996220, 713910, 980630, 094950, 094960, 094980, 455060, 705090, 798220, 325450, 250110, 255770, 250120, 350890, 541430. ***UDI Numbers*** (01)00880304551015(17)141007(10)860710, (01)00880304551015(17)141112(10)215430, (01)00880304551015(17)181231(10)555230, (01)00880304551015(17)181231(10)583850, (01)00880304551015(17)190209(10)089660, (01)00880304551015(17)190313(10)283370, (01)00880304551015(17)190505(10)132850, (01)00880304551015(17)190527(10)372710, (01)00880304551015(17)190527(10)372760, (01)00880304551015(17)190805(10)181880, (01)00880304551015(17)190819(10)357230, (01)00880304551015(17)190826(10)409110, (01)00880304551015(17)190826(10)409190, (01)00880304551015(17)190923(10)765360, (01)00880304551015(17)191103(10)196690, (01)00880304551015(17)191103(10)196700, (01)00880304551015(17)191103(10)196710, (01)00880304551015(17)191111(10)338960, (01)00880304551015(17)191201(10)511930, (01)00880304551015(17)191215(10)549800, (01)00880304551015(17)191229(10)706840, (01)00880304551015(17)200316(10)386790, (01)00880304551015(17)200414(10)445290, (01)00880304551015(17)200413(10)723200, (01)00880304551015(17)200505(10)024040, (01)00880304551015(17)200514(10)079210, (01)00880304551015(17)200527(10)262220, 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(01)00880304551015(17)210701(10)572910, (01)00880304551015(17)210705(10)698790, (01)00880304551015(17)210720(10)932210, (01)00880304551015(17)210919(10)637420, (01)00880304551015(17)210920(10)637430, (01)00880304551015(17)210920(10)637440, (01)00880304551015(17)220519(10)398110, (01)00880304551015(17)220518(10)398120, (01)00880304551015(17)220517(10)398140, (01)00880304551015(17)220519(10)398150, (01)00880304551015(17)220603(10)398160, (01)00880304551015(17)220603(10)789690, (01)00880304551015(17)220603(10)789700, (01)00880304551015(17)220608(10)789670, (01)00880304551015(17)220613(10)877260, (01)00880304551015(17)220701(10)202510, (01)00880304551015(17)201001(10)583060R, (01)00880304551015(17)210701(10)572910R, (01)00880304551015(17)220613(10)877260R, (01)00880304551015(17)220603(10)398160R, (01)00880304551015(17)221107(10)202500, (01)00880304551015(17)221103(10)809040, (01)00880304551015(17)230116(10)747440, (01)00880304551015(17)230204(10)916120, (01)00880304551015(17)230206(10)916130, (01)00880304551015(17)230204(10)916140, (01)00880304551015(17)230202(10)916150, (01)00880304551015(17)191215(10)549800R, (01)00880304551015(17)240205(10)349510, (01)00880304551015(17)240204(10)349530, (01)00880304551015(17)240211(10)349520, (01)00880304551015(17)240228(10)710630, (01)00880304551015(17)240308(10)710610, (01)00880304551015(17)240309(10)846580, (01)00880304551015(17)240311(10)846670, (01)00880304551015(17)240310(10)846740, (01)00880304551015(17)240315(10)895240, (01)00880304551015(17)240323(10)915400, (01)00880304551015(17)240320(10)963760, (01)00880304551015(17)240323(10)996210, (01)00880304551015(17)240323(10)996220, (01)00880304551015(17)240302(10)713910, (01)00880304551015(17)240515(10)980630, (01)00880304551015(17)240731(10)094950, (01)00880304551015(17)240731(10)094960, (01)00880304551015(17)240731(10)094980, (01)00880304551015(17)240622(10)455060, (01)00880304551015(17)240712(10)705090, (01)00880304551015(17)240801(10)798220, (01)00880304551015(17)240817(10)325450, (01)00880304551015(17)241009(10)250110, (01)00880304551015(17)241009(10)255770, (01)00880304551015(17)241023(10)250120, (01)00880304551015(17)241023(10)350890, (01)00880304551015(17)241110(10)541430
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