BIOMET StageOne recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

***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, (01)00880304551015(17)200527(10)262230, (01)00880304551015(17)200611(10)429560, (01)00880304551015(17)200725(10)821040, (01)00880304551015(17)200728(10)821050, (01)00880304551015(17)200730(10)960990, (01)00880304551015(17)200807(10)039770, (01)00880304551015(17)200928(10)399430, (01)00880304551015(17)200928(10)429450, (01)00880304551015(17)201001(10)583060, (01)00880304551015(17)201019(10)776890, (01)00880304551015(17)201106(10)938560, (01)00880304551015(17)201130(10)245080, (01)00880304551015(17)201201(10)245090, (01)00880304551015(17)201207(10)303380, (01)00880304551015(17)201218(10)443600, (01)00880304551015(17)210126(10)892230, (01)00880304551015(17)210114(10)751870, (01)00880304551015(17)210217(10)115420, (01)00880304551015(17)210224(10)186520, (01)00880304551015(17)210307(10)326920, (01)00880304551015(17)210323(10)513020, (01)00880304551015(17)210407(10)665290, (01)00880304551015(17)210427(10)978020, (01)00880304551015(17)210524(10)225130, (01)00880304551015(17)210607(10)424200, (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

Product

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

Recalling firm

Biomet, Inc.

Quantity

230,001

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.

Recall date

April 15, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)