FDAFDA · Food and drugs·Recall number Z-1651-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Published April 15, 2020 · Recall initiated: February 26, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- 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
- ***Lot Numbers*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 474150, 576700, 110750, 672080, 143910, 713260, 359270, 529160, 160630, 301450, 188850, 188840, 886920, 066020, 364260, 077620, 077630, 429820, 492480, 661200, 092850, 771050, 997420, 997410, 291970, 291870, 799190, 397000, 564140, 564130, 997410R, 809850, 809870, 809910, 224890, 548620, 809890, 916180, 070370, 224900, 224940, 224950, 164220, 164270, 164320, 224930, 295910, 388560, 388610, 388630, 552720, 552740, 388620, 552730, 737160, 875440, 989030, 291870R, 359270R, 799190R, 275380, 035010, 950420, 042970, 179530, 388620R, 717600, 717630, 777730, 356080, 717610, 717640, 777680, 777720, 864800, 864810, 864820, 864830, 879760, 063880, 164320R, 809910R, 224930R, 777710, 580090, 789080, 807580, 029320, 807550, 807560, 807590, 717620, 073260, 073270, 364280, 364300, 488070, 525680, 554710, 641750, 641840, 673840, 770190, 835130, 885470, 947000. ***UDI Numbers*** (01)00880304521131(17)160728(10)104910, (01)00880304521131(17)160728(10)157950, (01)00880304521131(17)160828(10)326900, (01)00880304521131(17)160728(10)326920, (01)00880304521131(17)160928(10)652840, (01)00880304521131(17)160930(10)684040, (01)00880304521131(17)170428(10)471600, (01)00880304521131(17)170528(10)593520, (01)00880304521131(17)170928(10)940120, (01)00880304521131(17)171128(10)437300, (01)00880304521131(17)171201(10)091520, (01)00880304521131(17)180204(10)474150, (01)00880304521131(17)180212(10)576700, (01)00880304521131(17)180412(10)110750, (01)00880304521131(17)180702(10)672080, (01)00880304521131(17)180820(10)143910, (01)00880304521131(17)181031(10)713260, (01)00880304521131(17)190707(10)359270, (01)00880304521131(17)190708(10)529160, (01)00880304521131(17)190822(10)160630, (01)00880304521131(17)190906(10)301450, (01)00880304521131(17)191202(10)188850, (01)00880304521131(17)191230(10)188840, (01)00880304521131(17)200204(10)886920, (01)00880304521131(17)200506(10)066020, (01)00880304521131(17)200505(10)364260, (01)00880304521131(17)200608(10)077620, (01)00880304521131(17)200609(10)077630, (01)00880304521131(17)200710(10)429820, (01)00880304521131(17)200727(10)492480, (01)00880304521131(17)200728(10)661200, (01)00880304521131(17)201001(10)092850, (01)00880304521131(17)201117(10)771050, (01)00880304521131(17)210228(10)997420, (01)00880304521131(17)210303(10)997410, (01)00880304521131(17)210706(10)291970, (01)00880304521131(17)210713(10)291870, (01)00880304521131(17)210830(10)799190, (01)00880304521131(17)210912(10)397000, (01)00880304521131(17)211102(10)564140, (01)00880304521131(17)220420(10)564130, (01)00880304521131(17)210303(10)997410R, (01)00880304521131(17)221203(10)809850, (01)00880304521131(17)221214(10)809870, (01)00880304521131(17)221218(10)809910, (01)00880304521131(17)230109(10)224890, (01)00880304521131(17)221231(10)548620, (01)00880304521131(17)221228(10)809890, (01)00880304521131(17)221231(10)916180, (01)00880304521131(17)230115(10)070370, (01)00880304521131(17)230115(10)224900, (01)00880304521131(17)230115(10)224940, (01)00880304521131(17)230115(10)224950, (01)00880304521131(17)230118(10)164220, (01)00880304521131(17)230124(10)164270, (01)00880304521131(17)230115(10)164320, (01)00880304521131(17)230118(10)224930, (01)00880304521131(17)230124(10)295910, (01)00880304521131(17)230119(10)388560, (01)00880304521131(17)230119(10)388610, (01)00880304521131(17)230124(10)388630, (01)00880304521131(17)230119(10)552720, (01)00880304521131(17)230124(10)552740, (01)00880304521131(17)230128(10)388620, (01)00880304521131(17)230124(10)552730, (01)00880304521131(17)230220(10)737160, (01)00880304521131(17)230227(10)875440, (01)00880304521131(17)230228(10)989030, (01)00880304521131(17)210713(10)291870R, (01)00880304521131(17)190707(10)359270R, (01)00880304521131(17)210830
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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