BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Enforcement
- Recall Number
- Z-1658-2020
- Event ID
- 85153
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 15, 2020
- Initiation Date
- February 26, 2020
- Classification Date
- April 3, 2020
- Termination Date
- July 29, 2021
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
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.
230,001