Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1658-2020)

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

Class II

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

***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

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.

Voluntary: Firm initiated