BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500, 453510, 546840, 546880, 547080, 940920, 437500, 437530, 477540, 546870, 974080, 105570, 226490, 547090, 071960, 105390, 799100R, 071940, 105470, 105550, 105460, 105480, 105510, 105520, 105430, 295490, 295500, 431310, 712100, 808020, 950370, 808030, 295470, 988850, 143520, 497700, 916880, 917200, 431520, 437530R, 478430, 478260, 478280, 478300, 478330, 478370, 478450, 518400, 518410, 518450, 518460, 478220, 570450, 639600, 639620, 639660, 639680, 639690, 644470, 661920, 661930, 661950, 662000, 261760, 261790, 276830, 661960, 661970, 661980, 662020, 518350, 661940, 696960, 696990, 455030, 570430, 639630, 661910, 696970, 697000, 697010, 697030, 813490, 813500, 845200, 845240, 845250, 845260, 845280, 845290, 845320, 845340, 845360, 877430, 877440, 877480, 877490, 877500, 063780, 084080, 037540, 063760, 171950, 210360, 210520, 210620, 772760, 777240, 788240, 806930, 838060, 894140, 028960, 900530, 330950, 364260, 073230, 465380, 488040, 554610, 605670, 605680, 623070, 641630, 673680, 673700, 673710, 673730, 689790, 689800, 758490, 810930, 810940, 834770, 834780, 834790, 885300, 518350R, 697030R, 885210, 644470R, 865720, 865730, 865770, 885240, 885270, 885280, 834810, 865750, 885220, 885250, 885310, 865670, 865700, 865740, 910020, 910060, 924640, 946710, 973850, 518420, 002310, 002320, 002330, 002340, 034900, 946720, 946730, 946750, 946760, 910040. ***UDI Numbers*** (01)00880304521230(17)160628(10)996010, (01)00880304521230(17)170328(10)795510, (01)00880304521230(17)170628(10)603900, (01)00880304521230(17)170928(10)891790, (01)00880304521230(17)171128(10)437190, (01)00880304521230(17)171128(10)735730, (01)00880304521230(17)180128(10)403040, (01)00880304521230(17)180204(10)474110, (01)00880304521230(17)180307(10)766880, (01)00880304521230(17)180306(10)819080, (01)00880304521230(17)180401(10)949560, (01)00880304521230(17)180401(10)982930, (01)00880304521230(17)180410(10)063520, (01)00880304521230(17)180509(10)277390, (01)00880304521230(17)180510(10)348170, (01)00880304521230(17)180621(10)649140, (01)00880304521230(17)180628(10)649130, 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- 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, 11 X 135 MM, Silicone, Sterile, Item 431191.
Product Codes/Lot Numbers:
***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500, 453510, 546840, 546880, 547080, 940920, 437500, 437530, 477540, 546870, 974080, 105570, 226490, 547090, 071960, 105390, 799100R, 071940, 105470, 105550, 105460, 105480, 105510, 105520, 105430, 295490, 295500, 431310, 712100, 808020, 950370, 808030, 295470, 988850, 143520, 497700, 916880, 917200, 431520, 437530R, 478430, 478260, 478280, 478300, 478330, 478370, 478450, 518400, 518410, 518450, 518460, 478220, 570450, 639600, 639620, 639660, 639680, 639690, 644470, 661920, 661930, 661950, 662000, 261760, 261790, 276830, 661960, 661970, 661980, 662020, 518350, 661940, 696960, 696990, 455030, 570430, 639630, 661910, 696970, 697000, 697010, 697030, 813490, 813500, 845200, 845240, 845250, 845260, 845280, 845290, 845320, 845340, 845360, 877430, 877440, 877480, 877490, 877500, 063780, 084080, 037540, 063760, 171950, 210360, 210520, 210620, 772760, 777240, 788240, 806930, 838060, 894140, 028960, 900530, 330950, 364260, 073230, 465380, 488040, 554610, 605670, 605680, 623070, 641630, 673680, 673700, 673710, 673730, 689790, 689800, 758490, 810930, 810940, 834770, 834780, 834790, 885300, 518350R, 697030R, 885210, 644470R, 865720, 865730, 865770, 885240, 885270, 885280, 834810, 865750, 885220, 885250, 885310, 865670, 865700, 865740, 910020, 910060, 924640, 946710, 973850, 518420, 002310, 002320, 002330, 002340, 034900, 946720, 946730, 946750, 946760, 910040. ***UDI Numbers*** (01)00880304521230(17)160628(10)996010, (01)00880304521230(17)170328(10)795510, (01)00880304521230(17)170628(10)603900, (01)00880304521230(17)170928(10)891790, (01)00880304521230(17)171128(10)437190, (01)00880304521230(17)171128(10)735730, (01)00880304521230(17)180128(10)403040, (01)00880304521230(17)180204(10)474110, (01)00880304521230(17)180307(10)766880, (01)00880304521230(17)180306(10)819080, (01)00880304521230(17)180401(10)949560, (01)00880304521230(17)180401(10)982930, (01)00880304521230(17)180410(10)063520, (01)00880304521230(17)180509(10)277390, (01)00880304521230(17)180510(10)348170, (01)00880304521230(17)180621(10)649140, (01)00880304521230(17)180628(10)649130, (01)00880304521230(17)180727(10)915350, (01)00880304521230(17)180809(10)093590, (01)00880304521230(17)180820(10)167540, (01)00880304521230(17)180826(10)265560, (01)00880304521230(17)180926(10)551780, (01)00880304521230(17)181028(10)135780, (01)00880304521230(17)181209(10)135790, (01)00880304521230(17)190116(10)584730, (01)00880304521230(17)190310(10)090420, (01)00880304521230(17)190409(10)359020, (01)00880304521230(17)190513(10)359030, (01)00880304521230(17)190603(10)262330, (01)00880304521230(17)190624(10)179770, (01)00880304521230(17)190628(10)467060, (01)00880304521230(17)190731(10)726970, (01)00880304521230(17)190822(10)158190, (01)00880304521230(17)190828(10)157740, (01)00880304521230(17)190927(10)588990, (01)00880304521230(17)191001(10)740300, (01)00880304521230(17)191030(10)056340, (01)00880304521230(17)191030(10)056350, (01)00880304521230(17)191125(10)188720, (01)00880304521230(17)191121(10)188730, (01)00880304521230(17)191124(10)188740, (01)00880304521230(17)191204(10)388660, (01)00880304521230(17)191217(10)388650, (01)00880304521230(17)191215(10)388690, (01)00880304521230(17)200320(10)354050, (01)00880304521230(17)200402(10)354040, (01)00880304521230(17)200410(10)061810, (01)00880304521230(17)200408(10)354020, (01)00880304521230(17)200505(10)816350, (01)00880304521230(17)200521(10)816380, (01)00880304521230(17)200609(10)077600, (01)00880304521230(17)200609(10)077610, (01)00880304521230(17)200611(10)124510, (01)00880304521230(17)200708(10)429530, (01)00880304521230(17)200707(10)429570, (01)00880304521230(17)200713(10)429590, (01)00880304521230(17)200805(10)655290, (01)00880304521230(17)200807(10)655270, (01)00880304521230(17)200806(10)663150, (01)00880304521230(17)200812(10)803110, (01)00880304521230(17)200827(10)940130, (01)00880304521230(17)200917(10)092340, (01)00880304521230(17)200916(10)110940, (01)00880304521230(17)201015(10)205710, 01)00880304521230(17)201106(10)757130, (01)00880304521230(17)201202(10)958250, (01)00880304521230(17)210108(10)332910, (01)00880304521230(17)210111(10)505420, (01)00880304521230(17)210108(10)505440, (01)00880304521230(17)210209(10)774400, (01)00880304521230(17)210209(10)774410, (01)00880304521230(17)210214(10)774420, (01)00880304521230(17)210228(10)967000, (01)00880304521230(17)210228(10)967010, (01)00880304521230(17)210225(10)967020, (01)00880304521230(17)210318(10)121310, (01)00880304521230(17)210505(10)842580, (01)00880304521230(17)210502(10)842590, (01)00880304521230(17)210509(10)842680, (01)00880304521230(17)210502(10)842790, (01)00880304521230(17)210526(10)054790, (01)00880304521230(17)210713(10)291800, (01)00880304521230(17)210819(10)799090, (01)00880304521230(17)210819(10)799100, (01)00880304521230(17)210823(10)799120, (01)00880304521230(17)210913(10)396760, (01)00880304521230(17)210912(10)396790, (01)00880304521230(17)210919(10)396750, (01)00880304521230(17)210916(10)396770, (01)00880304521230(17)220410(10)777410, (01)00880304521230(17)220411(10)777440, (01)00880304521230(17)200917(10)092340R, (01)00880304521230(17)200807(10)655270R, (01)00880304521230(17)220620(10)865810, (01)00880304521230(17)220619(10)865820, (01)00880304521230(17)220619(10)865830, (01)00880304521230(17)220626(10)945970, (01)00880304521230(17)210209(10)774410R, (01)00880304521230(17)221019(10)437480, (01)00880304521230(17)221019(10)437510, (01)00880304521230(17)221020(10)453400, (01)00880304521230(17)221023(10)477530, (01)00880304521230(17)221101(10)116030, (01)00880304521230(17)221103(10)437430, (01)00880304521230(17)221103(10)437540, (01)00880304521230(17)221103(10)437550, (01)00880304521230(17)221103(10)437560, (01)00880304521230(17)221101(10)453420, (01)00880304521230(17)221107(10)453490, (01)00880304521230(17)221103(10)453500, (01)00880304521230(17)221103(10)453510, (01)00880304521230(17)221102(10)546840, (01)00880304521230(17)221101(10)546880, (01)00880304521230(17)221025(10)547080, (01)00880304521230(17)221101(10)940920, (01)00880304521230(17)221103(10)437500, (01)00880304521230(17)221103(10)437530, (01)00880304521230(17)221111(10)477540, (01)00880304521230(17)221109(10)546870, (01)00880304521230(17)221101(10)974080, (01)00880304521230(17)221213(10)105570, (01)00880304521230(17)221118(10)226490, (01)00880304521230(17)221101(10)547090, (01)00880304521230(17)221228(10)071960, (01)00880304521230(17)221229(10)105390, (01)00880304521230(17)210819(10)799100R, (01)00880304521230(17)221229(10)071940, (01)00880304521230(17)230116(10)105470, (01)00880304521230(17)221229(10)105550, (01)00880304521230(17)230123(10)105460, (01)00880304521230(17)230117(10)105480, (01)00880304521230(17)230118(10)105510, (01)00880304521230(17)230127(10)105520, (01)00880304521230(17)230205(10)105430, (01)00880304521230(17)230205(10)295490, (01)00880304521230(17)230205(10)295500, (01)00880304521230(17)230205(10)431310, (01)00880304521230(17)230227(10)712100, (01)00880304521230(17)230227(10)808020, (01)00880304521230(17)230228(10)950370, (01)00880304521230(17)230312(10)808030, (01)00880304521230(17)230312(10)295470, (01)00880304521230(17)230320(10)988850, (01)00880304521230(17)230417(10)143520, (01)00880304521230(17)230417(10)497700, (01)00880304521230(17)230423(10)916880, (01)00880304521230(17)230422(10)917200, (01)00880304521230(17)230330(10)431520, (01)00880304521230(17)221103(10)437530R, (01)00880304521230(17)240502(10)478430, (01)00880304521230(17)240502(10)478260, (01)00880304521230(17)240502(10)478280, (01)00880304521230(17)240501(10)478300, (01)00880304521230(17)240502(10)478330, (01)00880304521230(17)240503(10)478370, (01)00880304521230(17)240503(10)478450, (01)00880304521230(17)240503(10)518400, (01)00880304521230(17)240502(10)518410, (01)00880304521230(17)240502(10)518450, (01)00880304521230(17)240502(10)518460, (01)00880304521230(17)240512(10)478220, (01)00880304521230(17)240512(10)570450, (01)00880304521230(17)240512(10)639600, (01)00880304521230(17)240512(10)639620, (01)00880304521230(17)240512(10)639660, (01)00880304521230(17)240513(10)639680, (01)00880304521230(17)240512(10)639690, (01)00880304521230(17)240513(10)644470, (01)00880304521230(17)240512(10)661920, (01)00880304521230(17)240512(10)661930, (01)00880304521230(17)240512(10)661950, (01)00880304521230(17)240512(10)662000, (01)00880304521230(17)240516(10)261760, (01)00880304521230(17)240513(10)261790, (01)00880304521230(17)240515(10)276830, (01)00880304521230(17)240516(10)661960, (01)00880304521230(17)240516(10)661970, (01)00880304521230(17)240516(10)661980, (01)00880304521230(17)240516(10)662020, (01)00880304521230(17)240524(10)518350, (01)00880304521230(17)240523(10)661940, (01)00880304521230(17)240527(10)696960, (01)00880304521230(17)240524(10)696990, (01)00880304521230(17)240731(10)455030, (01)00880304521230(17)240801(10)570430, (01)00880304521230(17)240610(10)639630, (01)00880304521230(17)240529(10)661910, (01)00880304521230(17)240528(10)696970, (01)00880304521230(17)240530(10)697000, (01)00880304521230(17)240528(10)697010, (01)00880304521230(17)240528(10)697030, (01)00880304521230(17)240614(10)813490, (01)00880304521230(17)240611(10)813500, (01)00880304521230(17)240607(10)845200, (01)00880304521230(17)240709(10)845240, (01)00880304521230(17)240615(10)845250, (01)00880304521230(17)240607(10)845260, (01)00880304521230(17)240611(10)845280, (01)00880304521230(17)240622(10)845290, (01)00880304521230(17)240608(10)845320, (01)00880304521230(17)240608(10)845340, (01)00880304521230(17)240620(10)845360, (01)00880304521230(17)240615(10)877430, (01)00880304521230(17)240615(10)877440, (01)00880304521230(17)240619(10)877480, (01)00880304521230(17)240614(10)877490, (01)00880304521230(17)240622(10)877500, (01)00880304521230(17)240816(10)063780, (01)00880304521230(17)240814(10)084080, (01)00880304521230(17)240901(10)037540, (01)00880304521230(17)240828(10)063760, (01)00880304521230(17)240828(10)171950, (01)00880304521230(17)240828(10)210360, (01)00880304521230(17)240829(10)210520, (01)00880304521230(17)240913(10)210620, (01)00880304521230(17)240925(10)772760, (01)00880304521230(17)240927(10)777240, (01)00880304521230(17)240926(10)788240, (01)00880304521230(17)240926(10)806930, (01)00880304521230(17)241004(10)838060, (01)00880304521230(17)241002(10)894140, (01)00880304521230(17)241009(10)028960, (01)00880304521230(17)241009(10)900530, (01)00880304521230(17)241022(10)330950, (01)00880304521230(17)241022(10)364260, (01)00880304521230(17)241010(10)073230, (01)00880304521230(17)241108(10)465380, (01)00880304521230(17)241110(10)488040, (01)00880304521230(17)241119(10)554610, (01)00880304521230(17)241119(10)605670, (01)00880304521230(17)241119(10)605680, (01)00880304521230(17)241119(10)623070, (01)00880304521230(17)241119(10)641630, (01)00880304521230(17)241205(10)673680, (01)00880304521230(17)241204(10)673700, (01)00880304521230(17)241204(10)673710, (01)00880304521230(17)241205(10)673730, (01)00880304521230(17)241205(10)689790, (01)00880304521230(17)241204(10)689800, (01)00880304521230(17)241204(10)758490, (01)00880304521230(17)241217(10)810930, (01)00880304521230(17)241217(10)810940, (01)00880304521230(17)241217(10)834770, (01)00880304521230(17)241216(10)834780, (01)00880304521230(17)241217(10)834790, (01)00880304521230(17)241217(10)885300, (01)00880304521230(17)240524(10)518350R, (01)00880304521230(17)240528(10)697030R, (01)00880304521230(17)241217(10)885210, (01)00880304521230(17)240513(10)644470R, (01)00880304521230(17)241230(10)865720, (01)00880304521230(17)241231(10)865730, (01)00880304521230(17)241230(10)865770, (01)00880304521230(17)241230(10)885240, (01)00880304521230(17)241230(10)885270, (01)00880304521230(17)241231(10)885280, (01)00880304521230(17)241216(10)834810, (01)00880304521230(17)241231(10)865750, (01)00880304521230(17)241231(10)885220, (01)00880304521230(17)250102(10)885250, (01)00880304521230(17)250102(10)885310, (01)00880304521230(17)250111(10)865670, (01)00880304521230(17)250110(10)865700, (01)00880304521230(17)250111(10)865740, (01)00880304521230(17)250110(10)910020, (01)00880304521230(17)250110(10)910060, (01)00880304521230(17)250110(10)924640, (01)00880304521230(17)250110(10)946710, (01)00880304521230(17)250110(10)973850, (01)00880304521230(17)240501(10)518420, (01)00880304521230(17)250121(10)002310, (01)00880304521230(17)250121(10)002320, (01)00880304521230(17)250121(10)002330, (01)00880304521230(17)250122(10)002340, (01)00880304521230(17)250122(10)034900, (01)00880304521230(17)250122(10)946720, (01)00880304521230(17)250122(10)946730, (01)00880304521230(17)250121(10)946750, (01)00880304521230(17)250122(10)946760, (01)00880304521230(17)250111(10)910040
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1644-2020
Related Recalls
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.