BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biomet, Inc.
- Reason for Recall:
- Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Product Codes/Lot Numbers:
***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
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1647-2020
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