Reported Apr 15, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
- Lot codes and dates
- ***Lot Numbers*** 978860, 087790, 087800, 157940, 558560, 564460, 052410, 052420, 052430, 052470, 052480, 230620, 230650, 575290, 767190, 766930, 789110, 031190, 031210, 031320, 265710, 349900, 654570, 927670, 767300, 817690, 188780, 188790, 932920, 205930, 429810, 655510, 092640, 757250, 771000, 683180, 803570, 217230, 197360, 291810, 799130, 552560, 974130, 249280, 249290, 233870, 188790R, 547700, 116180, 071090, 071100, 116160, 784730, 946240, 767190R, 487340, 552590, 655510R, 431450, 617650, 617770, 736810, 988930, 934780, 920630, 092640R, 552560R, 799130R, 920630R, 233870R, 291810R. ***UDI Numbers*** (01)00880304521155(17)160628(10)978860, (01)00880304521155(17)160728(10)087790, (01)00880304521155(17)160728(10)087800, (01)00880304521155(17)160728(10)157940, (01)00880304521155(17)160831(10)558560, (01)00880304521155(17)160928(10)564460, (01)00880304521155(17)170228(10)052410, (01)00880304521155(17)170228(10)052420, (01)00880304521155(17)170228(10)052430, (01)00880304521155(17)170228(10)052470, (01)00880304521155(17)170228(10)052480, (01)00880304521155(17)180108(10)230620, (01)00880304521155(17)180108(10)230650, (01)00880304521155(17)180215(10)575290, (01)00880304521155(17)180307(10)767190, (01)00880304521155(17)180330(10)766930, (01)00880304521155(17)180313(10)789110, (01)00880304521155(17)180430(10)031190, (01)00880304521155(17)180405(10)031210, (01)00880304521155(17)180405(10)031320, (01)00880304521155(17)181101(10)265710, (01)00880304521155(17)190101(10)349900, (01)00880304521155(17)190731(10)654570, (01)00880304521155(17)190807(10)927670, (01)00880304521155(17)190814(10)767300, (01)00880304521155(17)190813(10)817690, (01)00880304521155(17)191202(10)188780, (01)00880304521155(17)191204(10)188790, (01)00880304521155(17)200511(10)932920, (01)00880304521155(17)200609(10)205930, (01)00880304521155(17)200722(10)429810, (01)00880304521155(17)200805(10)655510, (01)00880304521155(17)201019(10)092640, (01)00880304521155(17)201109(10)757250, (01)00880304521155(17)201208(10)771000, (01)00880304521155(17)210215(10)683180, (01)00880304521155(17)210222(10)803570, (01)00880304521155(17)210321(10)217230, (01)00880304521155(17)210330(10)197360, (01)00880304521155(17)210616(10)291810, (01)00880304521155(17)210831(10)799130, (01)00880304521155(17)211105(10)552560, (01)00880304521155(17)220629(10)974130, (01)00880304521155(17)220518(10)249280, (01)00880304521155(17)220524(10)249290, (01)00880304521155(17)220726(10)233870, (01)00880304521155(17)191204(10)188790R, (01)00880304521155(17)221211(10)547700, (01)00880304521155(17)221219(10)116180, (01)00880304521155(17)221229(10)071090, (01)00880304521155(17)230109(10)071100, (01)00880304521155(17)221229(10)116160, (01)00880304521155(17)221227(10)784730, (01)00880304521155(17)230115(10)946240, (01)00880304521155(17)180307(10)767190R, (01)00880304521155(17)230320(10)487340, (01)00880304521155(17)230321(10)552590, (01)00880304521155(17)200805(10)655510R, (01)00880304521155(17)230321(10)431450, (01)00880304521155(17)230328(10)617650, (01)00880304521155(17)230416(10)617770, (01)00880304521155(17)230415(10)736810, (01)00880304521155(17)230412(10)988930, (01)00880304521155(17)230507(10)934780, (01)00880304521155(17)230511(10)920630, (01)00880304521155(17)201019(10)092640R, (01)00880304521155(17)211105(10)552560R, (01)00880304521155(17)210831(10)799130R, (01)00880304521155(17)230511(10)920630R, (01)00880304521155(17)220726(10)233870R, (01)00880304521155(17)210616(10)291810R
- Amount recalled
- 230,001
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
Why it was recalled
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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