BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 502050, 628160, 754710, 795480, 383860, 938730, 258280, 258190, 520980, 794470, 135080, 407080, 474100, 333620, 576720, 739510, 789340, 949520, 062820, 233420, 348160, 341200, 554920, 750800, 914960, 914980, 117230, 127860, 167340, 551760, 135720, 135760, 135770, 584700, 266500, 266520, 817710, 817680, 462720, 549240, 549340, 462600, 588980, 962650, 048960, 052030, 462420, 462470, 462500, 846510, 846550, 846660, 061800, 353690, 353770, 353730, 353790, 739210, 816110, 816220, 374890, 374880, 654990, 655000, 655010, 792120, 803200, 733600, 792110, 980400, 092160, 118970, 205620, 364700, 756370, 760140, 771060, 771070, 771080, 745790, 770910, 770920, 045110, 063710, 332900, 774490, 774480, 966970, 966990, 017840, 017580, 152210, 912450, 624130, 624140, 665090, 396720, 396730, 418450, 418460, 777400, 777430, 996050, 996060, 996070, 353770R, 092160R, 374890R, 654990R, 418460R, 810910, 864940, 864970, 777670, 906710, 996060R, 115970, 864960, 116000, 116020, 232620, 201250, 201280, 232550, 545970, 996050R, 232590, 232610, 201270, 201300, 269250, 269270, 269280, 269290, 269300, 269320, 269260, 269310, 201290, 401150, 401170, 401200, 888220, 875400, 988830, 034500, 848610, 256590, 377770, 495000, 275070, 377780, 766090, 942270, 942440, 916800, 916830, 942280, 942430, 777670R, 477940, 478080, 478180, 478200, 518250, 518260, 518290, 478150, 518240, 518280, 518310, 276800, 355820, 661780, 661790, 661800, 661880, 661740, 661860, 765320, 812830, 403850, 404010, 404050, 445450, 505080, 661750, 661760, 661840, 661850, 661890, 661900, 765300, 812840, 813460, 813480, 813700, 813710, 813720, 841860, 864630, 864710, 864760, 879790, 037330, 084060, 374880R, 803200R, 037530, 084040, 084050, 172140, 152380, 528120, 580040, 751390, 751400, 751430, 777220, 807610, 807650, 751410, 777210, 807600, 864670, 883840, 883860, 894050, 894060, 894080, 250560, 894100, 330940, 770920R, 465340, 465350, 465360, 488010, 488020, 503360, 605630, 605650, 605660, 641580, 641550, 723430, 723460, 723470, 276800R, 771080R, 812830R, 865620, 723440, 723450, 770210, 810920, 834760, 865610, 865630, 865640, 885100, 885150, 885170, 885200, 792640, 885110, 885120, 885130, 865650, 909870, 478210, 002300, 034890, 865660, 910000. ***UDI Numbers*** (01)00880304521995(17)160828(10)502050, (01)00880304521995(17)160928(10)628160, (01)00880304521995(17)170328(10)754710, (01)00880304521995(17)170328(10)795480, (01)00880304521995(17)170428(10)383860, (01)00880304521995(17)170928(10)938730, (01)00880304521995(17)171028(10)258280, (01)00880304521995(17)171028(10)258190, (01)00880304521995(17)171028(10)520980, (01)00880304521995(17)171128(10)794470, (01)00880304521995(17)171228(10)135080, (01)00880304521995(17)180117(10)407080, (01)00880304521995(17)180201(10)474100, (01)00880304521995(17)180212(10)333620, (01)00880304521995(17)180215(10)576720, (01)00880304521995(17)180307(10)739510, (01)00880304521995(17)180307(10)789340, 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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, 9 X 125 MM, Silicone, Sterile, Item 431190.
Product Codes/Lot Numbers:
***Lot Numbers*** 502050, 628160, 754710, 795480, 383860, 938730, 258280, 258190, 520980, 794470, 135080, 407080, 474100, 333620, 576720, 739510, 789340, 949520, 062820, 233420, 348160, 341200, 554920, 750800, 914960, 914980, 117230, 127860, 167340, 551760, 135720, 135760, 135770, 584700, 266500, 266520, 817710, 817680, 462720, 549240, 549340, 462600, 588980, 962650, 048960, 052030, 462420, 462470, 462500, 846510, 846550, 846660, 061800, 353690, 353770, 353730, 353790, 739210, 816110, 816220, 374890, 374880, 654990, 655000, 655010, 792120, 803200, 733600, 792110, 980400, 092160, 118970, 205620, 364700, 756370, 760140, 771060, 771070, 771080, 745790, 770910, 770920, 045110, 063710, 332900, 774490, 774480, 966970, 966990, 017840, 017580, 152210, 912450, 624130, 624140, 665090, 396720, 396730, 418450, 418460, 777400, 777430, 996050, 996060, 996070, 353770R, 092160R, 374890R, 654990R, 418460R, 810910, 864940, 864970, 777670, 906710, 996060R, 115970, 864960, 116000, 116020, 232620, 201250, 201280, 232550, 545970, 996050R, 232590, 232610, 201270, 201300, 269250, 269270, 269280, 269290, 269300, 269320, 269260, 269310, 201290, 401150, 401170, 401200, 888220, 875400, 988830, 034500, 848610, 256590, 377770, 495000, 275070, 377780, 766090, 942270, 942440, 916800, 916830, 942280, 942430, 777670R, 477940, 478080, 478180, 478200, 518250, 518260, 518290, 478150, 518240, 518280, 518310, 276800, 355820, 661780, 661790, 661800, 661880, 661740, 661860, 765320, 812830, 403850, 404010, 404050, 445450, 505080, 661750, 661760, 661840, 661850, 661890, 661900, 765300, 812840, 813460, 813480, 813700, 813710, 813720, 841860, 864630, 864710, 864760, 879790, 037330, 084060, 374880R, 803200R, 037530, 084040, 084050, 172140, 152380, 528120, 580040, 751390, 751400, 751430, 777220, 807610, 807650, 751410, 777210, 807600, 864670, 883840, 883860, 894050, 894060, 894080, 250560, 894100, 330940, 770920R, 465340, 465350, 465360, 488010, 488020, 503360, 605630, 605650, 605660, 641580, 641550, 723430, 723460, 723470, 276800R, 771080R, 812830R, 865620, 723440, 723450, 770210, 810920, 834760, 865610, 865630, 865640, 885100, 885150, 885170, 885200, 792640, 885110, 885120, 885130, 865650, 909870, 478210, 002300, 034890, 865660, 910000. ***UDI Numbers*** (01)00880304521995(17)160828(10)502050, (01)00880304521995(17)160928(10)628160, (01)00880304521995(17)170328(10)754710, (01)00880304521995(17)170328(10)795480, (01)00880304521995(17)170428(10)383860, (01)00880304521995(17)170928(10)938730, (01)00880304521995(17)171028(10)258280, (01)00880304521995(17)171028(10)258190, (01)00880304521995(17)171028(10)520980, (01)00880304521995(17)171128(10)794470, (01)00880304521995(17)171228(10)135080, (01)00880304521995(17)180117(10)407080, (01)00880304521995(17)180201(10)474100, (01)00880304521995(17)180212(10)333620, (01)00880304521995(17)180215(10)576720, (01)00880304521995(17)180307(10)739510, (01)00880304521995(17)180307(10)789340, (01)00880304521995(17)180401(10)949520, (01)00880304521995(17)180401(10)949530, (01)00880304521995(17)180405(10)062820, (01)00880304521995(17)180422(10)233420, (01)00880304521995(17)180509(10)348160, (01)00880304521995(17)180524(10)341200, (01)00880304521995(17)180619(10)554920, (01)00880304521995(17)180702(10)750800, (01)00880304521995(17)180726(10)914960, (01)00880304521995(17)180731(10)914980, (01)00880304521995(17)180817(10)117230, (01)00880304521995(17)180814(10)127860, (01)00880304521995(17)180820(10)167340, (01)00880304521995(17)180926(10)551760, (01)00880304521995(17)181127(10)135720, (01)00880304521995(17)181126(10)135760, (01)00880304521995(17)181209(10)135770, (01)00880304521995(17)190116(10)584700, (01)00880304521995(17)190408(10)266500, (01)00880304521995(17)190408(10)266520, (01)00880304521995(17)190515(10)817710, (01)00880304521995(17)190516(10)817680, (01)00880304521995(17)190624(10)462720, (01)00880304521995(17)190625(10)549240, (01)00880304521995(17)190625(10)549340, (01)00880304521995(17)190716(10)462600, (01)00880304521995(17)190926(10)588980, (01)00880304521995(17)191023(10)962650, (01)00880304521995(17)191103(10)048960, (01)00880304521995(17)191112(10)052030, (01)00880304521995(17)191215(10)462420, (01)00880304521995(17)191230(10)462470, (01)00880304521995(17)191215(10)462500, (01)00880304521995(17)200131(10)846510, (01)00880304521995(17)200131(10)846550, (01)00880304521995(17)200131(10)846660, (01)00880304521995(17)200314(10)061800, (01)00880304521995(17)200402(10)353690, (01)00880304521995(17)200403(10)353770, (01)00880304521995(17)200401(10)353730, (01)00880304521995(17)200408(10)353790, (01)00880304521995(17)200519(10)739210, (01)00880304521995(17)200514(10)816110, (01)00880304521995(17)200519(10)816220, (01)00880304521995(17)200707(10)374890, (01)00880304521995(17)200713(10)374880, (01)00880304521995(17)200806(10)654990, (01)00880304521995(17)200812(10)655000, (01)00880304521995(17)200805(10)655010, (01)00880304521995(17)200817(10)792120, (01)00880304521995(17)200813(10)803200, (01)00880304521995(17)200821(10)733600, (01)00880304521995(17)200820(10)792110, (01)00880304521995(17)200914(10)980400, (01)00880304521995(17)200918(10)092160, (01)00880304521995(17)200917(10)118970, (01)00880304521995(17)201015(10)205620, (01)00880304521995(17)201015(10)364700, (01)00880304521995(17)201105(10)756370, (01)00880304521995(17)201110(10)760140, (01)00880304521995(17)201116(10)771060, (01)00880304521995(17)201117(10)771070, (01)00880304521995(17)201117(10)771080, (01)00880304521995(17)201119(10)745790, (01)00880304521995(17)201120(10)770910, (01)00880304521995(17)201120(10)770920, (01)00880304521995(17)201202(10)045110, (01)00880304521995(17)210112(10)063710, (01)00880304521995(17)210212(10)332900, (01)00880304521995(17)210215(10)774490, (01)00880304521995(17)210217(10)774480, (01)00880304521995(17)210224(10)966970, (01)00880304521995(17)210224(10)966990, (01)00880304521995(17)210308(10)017840, (01)00880304521995(17)210309(10)017580, (01)00880304521995(17)210325(10)152210, (01)00880304521995(17)210526(10)912450, (01)00880304521995(17)210527(10)912460, (01)00880304521995(17)210722(10)624130, (01)00880304521995(17)210721(10)624140, (01)00880304521995(17)210722(10)665090, (01)00880304521995(17)210912(10)396720, (01)00880304521995(17)210912(10)396730, (01)00880304521995(17)210919(10)418450, (01)00880304521995(17)210919(10)418460, (01)00880304521995(17)220408(10)777400, (01)00880304521995(17)220408(10)777430, (01)00880304521995(17)220409(10)996050, (01)00880304521995(17)220410(10)996060, (01)00880304521995(17)220411(10)996070, (01)00880304521995(17)200403(10)353770R, (01)00880304521995(17)200918(10)092160R, (01)00880304521995(17)200707(10)374890R, (01)00880304521995(17)200806(10)654990R, (01)00880304521995(17)210919(10)418460R, (01)00880304521995(17)220619(10)810910, (01)00880304521995(17)220620(10)864940, (01)00880304521995(17)220620(10)864970, (01)00880304521995(17)220615(10)777670, (01)00880304521995(17)220628(10)906710, (01)00880304521995(17)220410(10)996060R, (01)00880304521995(17)220722(10)115970, (01)00880304521995(17)220627(10)864960, (01)00880304521995(17)220723(10)116000, (01)00880304521995(17)220723(10)116020, (01)00880304521995(17)220823(10)232620, (01)00880304521995(17)221003(10)201250, (01)00880304521995(17)221002(10)201280, (01)00880304521995(17)220929(10)232550, (01)00880304521995(17)220929(10)545970, (01)00880304521995(17)220409(10)996050R, (01)00880304521995(17)221003(10)232590, (01)00880304521995(17)221005(10)232610, (01)00880304521995(17)221012(10)201270, (01)00880304521995(17)221020(10)201300, (01)00880304521995(17)221023(10)269250, (01)00880304521995(17)221018(10)269270, (01)00880304521995(17)221019(10)269280, (01)00880304521995(17)221103(10)269290, (01)00880304521995(17)221101(10)269300, (01)00880304521995(17)221103(10)269320, (01)00880304521995(17)221111(10)269260, (01)00880304521995(17)221109(10)269310, (01)00880304521995(17)230116(10)201290, (01)00880304521995(17)230116(10)401150, (01)00880304521995(17)230116(10)401170, (01)00880304521995(17)230117(10)401200, (01)00880304521995(17)230205(10)888220, (01)00880304521995(17)230221(10)875400, (01)00880304521995(17)230222(10)988830, (01)00880304521995(17)230228(10)034500, (01)00880304521995(17)230221(10)848610, (01)00880304521995(17)230319(10)256590, (01)00880304521995(17)230319(10)377770, (01)00880304521995(17)230320(10)495000, (01)00880304521995(17)230330(10)275070, (01)00880304521995(17)230410(10)377780, (01)00880304521995(17)230417(10)766090, (01)00880304521995(17)230417(10)942270, (01)00880304521995(17)230417(10)942440, (01)00880304521995(17)230423(10)916800, (01)00880304521995(17)230420(10)916830, (01)00880304521995(17)230417(10)942280, (01)00880304521995(17)230424(10)942430, (01)00880304521995(17)220615(10)777670R, (01)00880304521995(17)240501(10)477940, (01)00880304521995(17)240501(10)478080, (01)00880304521995(17)240501(10)478180, (01)00880304521995(17)240501(10)478200, (01)00880304521995(17)240501(10)518250, (01)00880304521995(17)240501(10)518260, (01)00880304521995(17)240501(10)518290, (01)00880304521995(17)240501(10)478150, (01)00880304521995(17)240502(10)518240, (01)00880304521995(17)240502(10)518280, (01)00880304521995(17)240503(10)518310, (01)00880304521995(17)240513(10)276800, (01)00880304521995(17)240512(10)355820, (01)00880304521995(17)240516(10)661780, (01)00880304521995(17)240517(10)661790, (01)00880304521995(17)240516(10)661800, (01)00880304521995(17)240516(10)661880, (01)00880304521995(17)240523(10)661740, (01)00880304521995(17)240524(10)661860, (01)00880304521995(17)240527(10)765320, (01)00880304521995(17)240611(10)812830, (01)00880304521995(17)240629(10)403850, (01)00880304521995(17)240628(10)404010, (01)00880304521995(17)240622(10)404050, (01)00880304521995(17)240628(10)445450, (01)00880304521995(17)240802(10)505080, (01)00880304521995(17)240527(10)661750, (01)00880304521995(17)240528(10)661760, (01)00880304521995(17)240528(10)661840, (01)00880304521995(17)240527(10)661850, (01)00880304521995(17)240610(10)661890, (01)00880304521995(17)240527(10)661900, (01)00880304521995(17)240529(10)765300, (01)00880304521995(17)240614(10)812840, (01)00880304521995(17)240612(10)813460, (01)00880304521995(17)240610(10)813480 (01)00880304521995(17)240612(10)813700, (01)00880304521995(17)240801(10)813710, (01)00880304521995(17)240614(10)813720, (01)00880304521995(17)240622(10)841860, (01)00880304521995(17)240622(10)864630, (01)00880304521995(17)240607(10)864710, (01)00880304521995(17)240607(10)864760, (01)00880304521995(17)240614(10)879790, (01)00880304521995(17)240814(10)037330, (01)00880304521995(17)240815(10)084060, (01)00880304521995(17)200713(10)374880R, (01)00880304521995(17)200813(10)803200R, (01)00880304521995(17)240828(10)037530, (01)00880304521995(17)240828(10)084040, (01)00880304521995(17)240828(10)084050, (01)00880304521995(17)240828(10)172140, (01)00880304521995(17)240915(10)152380, (01)00880304521995(17)240913(10)528120, (01)00880304521995(17)240925(10)580040, (01)00880304521995(17)240925(10)751390, (01)00880304521995(17)240925(10)751400, (01)00880304521995(17)240924(10)751430, (01)00880304521995(17)240926(10)777220, (01)00880304521995(17)240926(10)807610, (01)00880304521995(17)240926(10)807650, (01)00880304521995(17)241002(10)751410, (01)00880304521995(17)241003(10)777210, (01)00880304521995(17)241003(10)807600, (01)00880304521995(17)241003(10)864670, (01)00880304521995(17)241002(10)883840, (01)00880304521995(17)241003(10)883860, (01)00880304521995(17)241002(10)894050, (01)00880304521995(17)241003(10)894060, (01)00880304521995(17)241003(10)894080, (01)00880304521995(17)241012(10)250560, (01)00880304521995(17)241009(10)894100, (01)00880304521995(17)241022(10)330940, (01)00880304521995(17)201120(10)770920R, (01)00880304521995(17)241110(10)465340, (01)00880304521995(17)241107(10)465350, (01)00880304521995(17)241107(10)465360, (01)00880304521995(17)241107(10)488010, (01)00880304521995(17)241108(10)488020, (01)00880304521995(17)241107(10)503360, (01)00880304521995(17)241119(10)605630, (01)00880304521995(17)241119(10)605650, (01)00880304521995(17)241119(10)605660, (01)00880304521995(17)241119(10)641580, (01)00880304521995(17)241120(10)641550, (01)00880304521995(17)241210(10)723430, (01)00880304521995(17)241208(10)723460, (01)00880304521995(17)241206(10)723470, (01)00880304521995(17)240513(10)276800R, (01)00880304521995(17)201117(10)771080R, (01)00880304521995(17)240611(10)812830R, (01)00880304521995(17)241217(10)865620, (01)00880304521995(17)241218(10)723440, (01)00880304521995(17)241217(10)723450, (01)00880304521995(17)241218(10)770210, (01)00880304521995(17)241217(10)810920, (01)00880304521995(17)241218(10)834760, 01)00880304521995(17)241218(10)865610, (01)00880304521995(17)241218(10)865630, (01)00880304521995(17)241231(10)865640, (01)00880304521995(17)241231(10)885100, (01)00880304521995(17)241231(10)885150, (01)00880304521995(17)241231(10)885170, (01)00880304521995(17)241231(10)885200, (01)00880304521995(17)250102(10)792640, (01)00880304521995(17)241231(10)885110, (01)00880304521995(17)250102(10)885120, (01)00880304521995(17)241231(10)885130, (01)00880304521995(17)250113(10)865650, (01)00880304521995(17)250111(10)909870, (01)00880304521995(17)240501(10)478210, (01)00880304521995(17)250122(10)002300, (01)00880304521995(17)250120(10)034890, (01)00880304521995(17)250116(10)865660, (01)00880304521995(17)250121(10)910000
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1643-2020
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.