BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 135090, 341030, 262420, 789510, 843130, 843140, 020980, 063530, 258130, 306890, 554960, 916060, 143900, 369930, 713250, 068170, 135800, 387420, 266430, 817720, 424890, 271580, 467100, 158310, 158320, 158330, 063490, 188750, 188760, 388720, 847530, 061820, 354330, 354340, 816470, 816710, 374910, 374920, 374940, 670140, 655470, 792140, 655460, 722930, 792130, 092510, 205800, 364730, 655480, 759150, 771240, 799960, 770950, 770970, 064050, 981350, 691930, 683120, 683170, 683150, 803380, 691880, 912490, 912500, 624150, 624160, 444030, 564610, 563840, 996120, 777720, 777730, 866050, 866070, 444030R, 655460R, 205800R, 116150, 232830, 946080, 232790, 232820, 438450, 453800, 453820, 453840, 477550, 477580, 477590, 547510, 438360, 438420, 453810, 453850, 477570, 477600, 547520, 784740, 438280, 438320, 438380, 547470, 561190, 547490, 453750, 946070, 164130, 453780, 164140, 431330, 683120R, 034680, 950380, 988870, 618540, 875430, 988910, 275310, 303400, 736780, 143600, 438220, 438430, 934880, 935040, 042490, 453750R, 770970R, 518530, 478470, 478480, 478500, 518520, 518540, 261860, 518500, 639250, 639280, 639310, 639350, 639370, 639380, 639240, 639270, 639340, 662040, 662060, 518510, 778040, 518490, 662080, 261870, 403980, 662050, 717850, 742340, 777310, 777330, 777340, 777380, 778100, 812880, 812890, 813510, 813530, 845400, 845420, 845440, 845450, 845470, 845480, 877510, 877530, 518470, 063800, 092510R, 374910R, 063790, 063810, 210670, 210690, 639300, 777250, 788250, 788430, 807220, 788200, 788420, 806950, 806960, 807210, 894160, 028970, 029010, 029020, 807200, 894150, 331320, 330960, 438360R, 465390, 465400, 503380, 503450, 503850, 641640, 641670, 689810, 689820, 689830, 723480, 723490, 723500, 723530, 834840, 865820, 865840, 834830, 834850, 865810, 723540, 865800, 865830, 910070, 910080, 002410, 946770, 946780, 946790, 946800, 946820. ***UDI Numbers*** (01)00880304521247(17)160128(10)838930, (01)00880304521247(17)170128(10)799860, (01)00880304521247(17)170228(10)764700, (01)00880304521247(17)170428(10)371690, (01)00880304521247(17)170428(10)371700, (01)00880304521247(17)170828(10)574530, (01)00880304521247(17)170928(10)062130, (01)00880304521247(17)170928(10)939190, (01)00880304521247(17)171028(10)258290, (01)00880304521247(17)171206(10)874960, (01)00880304521247(17)171228(10)717990, (01)00880304521247(17)171220(10)135090, (01)00880304521247(17)180117(10)341030, (01)00880304521247(17)180211(10)262420, (01)00880304521247(17)180307(10)789510, (01)00880304521247(17)180307(10)843130, (01)00880304521247(17)180311(10)843140, (01)00880304521247(17)180405(10)020980, (01)00880304521247(17)180411(10)063530, (01)00880304521247(17)180503(10)258130, (01)00880304521247(17)180503(10)306890, (01)00880304521247(17)180624(10)554960, (01)00880304521247(17)180727(10)916060, (01)00880304521247(17)180814(10)143900, (01)00880304521247(17)180904(10)369930, (01)00880304521247(17)181025(10)713250, (01)00880304521247(17)181209(10)068170, (01)00880304521247(17)181209(10)135800, (01)00880304521247(17)190102(10)387420, (01)00880304521247(17)190408(10)266430, (01)00880304521247(17)190529(10)817720, (01)00880304521247(17)190624(10)424890, (01)00880304521247(17)190627(10)271580, (01)00880304521247(17)190627(10)467100, (01)00880304521247(17)190825(10)158310, (01)00880304521247(17)190820(10)158320, (01)00880304521247(17)190820(10)158330, (01)00880304521247(17)191104(10)063490, (01)00880304521247(17)191124(10)188750, (01)00880304521247(17)191124(10)188760, (01)00880304521247(17)191212(10)388720, (01)00880304521247(17)200131(10)847530, (01)00880304521247(17)200314(10)061820, (01)00880304521247(17)200402(10)354330, (01)00880304521247(17)200408(10)354340, (01)00880304521247(17)200504(10)816470, (01)00880304521247(17)200515(10)816710, (01)00880304521247(17)200707(10)374910, (01)00880304521247(17)200702(10)374920, (01)00880304521247(17)200707(10)374940, (01)00880304521247(17)200803(10)670140, (01)00880304521247(17)200807(10)655470, (01)00880304521247(17)200812(10)792140, (01)00880304521247(17)200813(10)655460, (01)00880304521247(17)200819(10)722930, (01)00880304521247(17)200821(10)792130, (01)00880304521247(17)200917(10)092510, (01)00880304521247(17)200917(10)205800, (01)00880304521247(17)201016(10)364730, (01)00880304521247(17)201022(10)655480, (01)00880304521247(17)201106(10)759150, (01)00880304521247(17)201110(10)771240, (01)00880304521247(17)201111(10)799960, (01)00880304521247(17)201118(10)770950, (01)00880304521247(17)201118(10)770970, (01)00880304521247(17)201202(10)064050, (01)00880304521247(17)201202(10)981350, (01)00880304521247(17)210203(10)691930, (01)00880304521247(17)210209(10)683120, (01)00880304521247(17)210209(10)683170, (01)00880304521247(17)210211(10)683150, (01)00880304521247(17)210212(10)803380, (01)00880304521247(17)210217(10)691880, (01)00880304521247(17)210517(10)912490, (01)00880304521247(17)210524(10)912500, (01)00880304521247(17)210722(10)624150, (01)00880304521247(17)210721(10)624160, (01)00880304521247(17)210921(10)444030, (01)00880304521247(17)211115(10)564610, (01)00880304521247(17)211120(10)563840, (01)00880304521247(17)220104(10)996120, (01)00880304521247(17)220410(10)777720, (01)00880304521247(17)220410(10)777730, (01)00880304521247(17)220619(10)866050, (01)00880304521247(17)220620(10)866070, (01)00880304521247(17)210921(10)444030R, (01)00880304521247(17)200813(10)655460R, (01)00880304521247(17)200917(10)205800R, (01)00880304521247(17)220722(10)116150, (01)00880304521247(17)220727(10)232830, (01)00880304521247(17)220726(10)946080, (01)00880304521247(17)221107(10)232790, (01)00880304521247(17)221102(10)232820, (01)00880304521247(17)221102(10)438450, (01)00880304521247(17)221103(10)453760, (01)00880304521247(17)221102(10)453800, (01)00880304521247(17)221103(10)453820, (01)00880304521247(17)221103(10)453840, (01)00880304521247(17)221103(10)477550, (01)00880304521247(17)221102(10)477580, (01)00880304521247(17)221103(10)477590, (01)00880304521247(17)221103(10)547510, (01)00880304521247(17)221109(10)438360, (01)00880304521247(17)221109(10)438420, (01)00880304521247(17)221102(10)453810, (01)00880304521247(17)221103(10)453850, (01)00880304521247(17)221111(10)477570, (01)00880304521247(17)221111(10)477600, (01)00880304521247(17)221108(10)547520, (01)00880304521247(17)221111(10)784740, (01)00880304521247(17)221121(10)438280, (01)00880304521247(17)221117(10)438320, (01)00880304521247(17)221117(10)438380, (01)00880304521247(17)221120(10)547470, (01)00880304521247(17)221125(10)561190, (01)00880304521247(17)221103(10)547490, (01)00880304521247(17)221213(10)453750, (01)00880304521247(17)221216(10)946070, (01)00880304521247(17)221229(10)164130, (01)00880304521247(17)230102(10)453780, (01)00880304521247(17)230111(10)164140, (01)00880304521247(17)230116(10)431330, (01)00880304521247(17)210209(10)683120R, (01)00880304521247(17)230312(10)034680, (01)00880304521247(17)230311(10)950380, (01)00880304521247(17)230312(10)988870, (01)00880304521247(17)230319(10)618540, (01)00880304521247(17)230319(10)875430, (01)00880304521247(17)230320(10)988910, (01)00880304521247(17)230416(10)275310, (01)00880304521247(17)230417(10)303400, (01)00880304521247(17)230417(10)736780, (01)00880304521247(17)230423(10)143600, (01)00880304521247(17)221115(10)438220, (01)00880304521247(17)230423(10)438430, (01)00880304521247(17)230502(10)934880, (01)00880304521247(17)230502(10)935040, (01)00880304521247(17)230521(10)042490, (01)00880304521247(17)221213(10)453750R, (01)00880304521247(17)201118(10)770970R, (01)00880304521247(17)240501(10)518530, (01)00880304521247(17)240501(10)478470, (01)00880304521247(17)240503(10)478480, (01)00880304521247(17)240503(10)478500, (01)00880304521247(17)240501(10)518520, (01)00880304521247(17)240502(10)518540, (01)00880304521247(17)240513(10)261860, (01)00880304521247(17)240513(10)518500, (01)00880304521247(17)240512(10)639250, (01)00880304521247(17)240513(10)639280, (01)00880304521247(17)240512(10)639310, (01)00880304521247(17)240513(10)639350, (01)00880304521247(17)240512(10)639370, (01)00880304521247(17)240512(10)639380, (01)00880304521247(17)240515(10)639240, (01)00880304521247(17)240515(10)639270, (01)00880304521247(17)240515(10)639340, (01)00880304521247(17)240516(10)662040, (01)00880304521247(17)240516(10)662060, (01)00880304521247(17)240525(10)518510, (01)00880304521247(17)240526(10)778040, (01)00880304521247(17)240607(10)518490, (01)00880304521247(17)240609(10)662080, (01)00880304521247(17)240515(10)261870, (01)00880304521247(17)240628(10)403980, (01)00880304521247(17)240601(10)662050, (01)00880304521247(17)240611(10)717850, (01)00880304521247(17)240802(10)742340, (01)00880304521247(17)240526(10)777310, (01)00880304521247(17)240528(10)777330, (01)00880304521247(17)240702(10)777340, (01)00880304521247(17)240622(10)777380, (01)00880304521247(17)240528(10)778100, (01)00880304521247(17)240612(10)812880, (01)00880304521247(17)240802(10)812890, (01)00880304521247(17)240615(10)813510, (01)00880304521247(17)240611(10)813530, (01)00880304521247(17)240622(10)845400, (01)00880304521247(17)240620(10)845420, (01)00880304521247(17)240620(10)845440, (01)00880304521247(17)240801(10)845450, (01)00880304521247(17)240622(10)845470, (01)00880304521247(17)240620(10)845480, (01)00880304521247(17)240617(10)877510, (01)00880304521247(17)240614(10)877530, (01)00880304521247(17)240805(10)518470, (01)00880304521247(17)240816(10)063800, (01)00880304521247(17)200917(10)092510R, (01)00880304521247(17)200707(10)374910R, (01)00880304521247(17)240828(10)063790, (01)00880304521247(17)240828(10)063810, (01)00880304521247(17)240828(10)210670, (01)00880304521247(17)240828(10)210690, (01)00880304521247(17)240927(10)639300, (01)00880304521247(17)240926(10)777250, (01)00880304521247(17)240926(10)788250, (01)00880304521247(17)240927(10)788430, (01)00880304521247(17)240927(10)807220, (01)00880304521247(17)241003(10)788200, (01)00880304521247(17)241003(10)788420, (01)00880304521247(17)241003(10)806950, (01)00880304521247(17)241003(10)806960, (01)00880304521247(17)241003(10)807210, (01)00880304521247(17)241003(10)894160, (01)00880304521247(17)241010(10)028970, (01)00880304521247(17)241010(10)029010, (01)00880304521247(17)241010(10)029020, (01)00880304521247(17)241009(10)807200, (01)00880304521247(17)241008(10)894150, (01)00880304521247(17)241022(10)331320, (01)00880304521247(17)241023(10)330960, (01)00880304521247(17)221109(10)438360R, (01)00880304521247(17)241110(10)465390, (01)00880304521247(17)241110(10)465400, (01)00880304521247(17)241110(10)503380, (01)00880304521247(17)241108(10)503450, (01)00880304521247(17)241107(10)503850, (01)00880304521247(17)241119(10)641640, (01)00880304521247(17)241119(10)641670, (01)00880304521247(17)241206(10)689810, (01)00880304521247(17)241206(10)689820, (01)00880304521247(17)241208(10)689830, (01)00880304521247(17)241208(10)723480, (01)00880304521247(17)241209(10)723490, (01)00880304521247(17)241208(10)723500, (01)00880304521247(17)241208(10)723530, (01)00880304521247(17)241217(10)834840, (01)00880304521247(17)241218(10)834860, (01)00880304521247(17)241217(10)865820, (01)00880304521247(17)241218(10)865840, (01)00880304521247(17)241218(10)834830, (01)00880304521247(17)241218(10)834850, (01)00880304521247(17)241218(10)865810, (01)00880304521247(17)250102(10)723540, (01)00880304521247(17)250102(10)865800, (01)00880304521247(17)241217(10)865830, (01)00880304521247(17)250111(10)910070, (01)00880304521247(17)250113(10)910080, (01)00880304521247(17)250122(10)002410, (01)00880304521247(17)250121(10)946770, (01)00880304521247(17)250121(10)946780, (01)00880304521247(17)250122(10)946790, (01)00880304521247(17)250122(10)946800 (01)00880304521247(17)250121(10)946820
- 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, 13 X 145 MM, Silicone, Sterile, Item 431192.
Product Codes/Lot Numbers:
***Lot Numbers*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 135090, 341030, 262420, 789510, 843130, 843140, 020980, 063530, 258130, 306890, 554960, 916060, 143900, 369930, 713250, 068170, 135800, 387420, 266430, 817720, 424890, 271580, 467100, 158310, 158320, 158330, 063490, 188750, 188760, 388720, 847530, 061820, 354330, 354340, 816470, 816710, 374910, 374920, 374940, 670140, 655470, 792140, 655460, 722930, 792130, 092510, 205800, 364730, 655480, 759150, 771240, 799960, 770950, 770970, 064050, 981350, 691930, 683120, 683170, 683150, 803380, 691880, 912490, 912500, 624150, 624160, 444030, 564610, 563840, 996120, 777720, 777730, 866050, 866070, 444030R, 655460R, 205800R, 116150, 232830, 946080, 232790, 232820, 438450, 453800, 453820, 453840, 477550, 477580, 477590, 547510, 438360, 438420, 453810, 453850, 477570, 477600, 547520, 784740, 438280, 438320, 438380, 547470, 561190, 547490, 453750, 946070, 164130, 453780, 164140, 431330, 683120R, 034680, 950380, 988870, 618540, 875430, 988910, 275310, 303400, 736780, 143600, 438220, 438430, 934880, 935040, 042490, 453750R, 770970R, 518530, 478470, 478480, 478500, 518520, 518540, 261860, 518500, 639250, 639280, 639310, 639350, 639370, 639380, 639240, 639270, 639340, 662040, 662060, 518510, 778040, 518490, 662080, 261870, 403980, 662050, 717850, 742340, 777310, 777330, 777340, 777380, 778100, 812880, 812890, 813510, 813530, 845400, 845420, 845440, 845450, 845470, 845480, 877510, 877530, 518470, 063800, 092510R, 374910R, 063790, 063810, 210670, 210690, 639300, 777250, 788250, 788430, 807220, 788200, 788420, 806950, 806960, 807210, 894160, 028970, 029010, 029020, 807200, 894150, 331320, 330960, 438360R, 465390, 465400, 503380, 503450, 503850, 641640, 641670, 689810, 689820, 689830, 723480, 723490, 723500, 723530, 834840, 865820, 865840, 834830, 834850, 865810, 723540, 865800, 865830, 910070, 910080, 002410, 946770, 946780, 946790, 946800, 946820. ***UDI Numbers*** (01)00880304521247(17)160128(10)838930, (01)00880304521247(17)170128(10)799860, (01)00880304521247(17)170228(10)764700, (01)00880304521247(17)170428(10)371690, (01)00880304521247(17)170428(10)371700, (01)00880304521247(17)170828(10)574530, (01)00880304521247(17)170928(10)062130, (01)00880304521247(17)170928(10)939190, (01)00880304521247(17)171028(10)258290, (01)00880304521247(17)171206(10)874960, (01)00880304521247(17)171228(10)717990, (01)00880304521247(17)171220(10)135090, (01)00880304521247(17)180117(10)341030, (01)00880304521247(17)180211(10)262420, (01)00880304521247(17)180307(10)789510, (01)00880304521247(17)180307(10)843130, (01)00880304521247(17)180311(10)843140, (01)00880304521247(17)180405(10)020980, (01)00880304521247(17)180411(10)063530, (01)00880304521247(17)180503(10)258130, (01)00880304521247(17)180503(10)306890, (01)00880304521247(17)180624(10)554960, (01)00880304521247(17)180727(10)916060, (01)00880304521247(17)180814(10)143900, (01)00880304521247(17)180904(10)369930, (01)00880304521247(17)181025(10)713250, (01)00880304521247(17)181209(10)068170, (01)00880304521247(17)181209(10)135800, (01)00880304521247(17)190102(10)387420, (01)00880304521247(17)190408(10)266430, (01)00880304521247(17)190529(10)817720, (01)00880304521247(17)190624(10)424890, (01)00880304521247(17)190627(10)271580, (01)00880304521247(17)190627(10)467100, (01)00880304521247(17)190825(10)158310, (01)00880304521247(17)190820(10)158320, (01)00880304521247(17)190820(10)158330, (01)00880304521247(17)191104(10)063490, (01)00880304521247(17)191124(10)188750, (01)00880304521247(17)191124(10)188760, (01)00880304521247(17)191212(10)388720, (01)00880304521247(17)200131(10)847530, (01)00880304521247(17)200314(10)061820, (01)00880304521247(17)200402(10)354330, (01)00880304521247(17)200408(10)354340, (01)00880304521247(17)200504(10)816470, (01)00880304521247(17)200515(10)816710, (01)00880304521247(17)200707(10)374910, (01)00880304521247(17)200702(10)374920, (01)00880304521247(17)200707(10)374940, (01)00880304521247(17)200803(10)670140, (01)00880304521247(17)200807(10)655470, (01)00880304521247(17)200812(10)792140, (01)00880304521247(17)200813(10)655460, (01)00880304521247(17)200819(10)722930, (01)00880304521247(17)200821(10)792130, (01)00880304521247(17)200917(10)092510, (01)00880304521247(17)200917(10)205800, (01)00880304521247(17)201016(10)364730, (01)00880304521247(17)201022(10)655480, (01)00880304521247(17)201106(10)759150, (01)00880304521247(17)201110(10)771240, (01)00880304521247(17)201111(10)799960, (01)00880304521247(17)201118(10)770950, (01)00880304521247(17)201118(10)770970, (01)00880304521247(17)201202(10)064050, (01)00880304521247(17)201202(10)981350, (01)00880304521247(17)210203(10)691930, (01)00880304521247(17)210209(10)683120, (01)00880304521247(17)210209(10)683170, (01)00880304521247(17)210211(10)683150, (01)00880304521247(17)210212(10)803380, (01)00880304521247(17)210217(10)691880, (01)00880304521247(17)210517(10)912490, (01)00880304521247(17)210524(10)912500, (01)00880304521247(17)210722(10)624150, (01)00880304521247(17)210721(10)624160, (01)00880304521247(17)210921(10)444030, (01)00880304521247(17)211115(10)564610, (01)00880304521247(17)211120(10)563840, (01)00880304521247(17)220104(10)996120, (01)00880304521247(17)220410(10)777720, (01)00880304521247(17)220410(10)777730, (01)00880304521247(17)220619(10)866050, (01)00880304521247(17)220620(10)866070, (01)00880304521247(17)210921(10)444030R, (01)00880304521247(17)200813(10)655460R, (01)00880304521247(17)200917(10)205800R, (01)00880304521247(17)220722(10)116150, (01)00880304521247(17)220727(10)232830, (01)00880304521247(17)220726(10)946080, (01)00880304521247(17)221107(10)232790, (01)00880304521247(17)221102(10)232820, (01)00880304521247(17)221102(10)438450, (01)00880304521247(17)221103(10)453760, (01)00880304521247(17)221102(10)453800, (01)00880304521247(17)221103(10)453820, (01)00880304521247(17)221103(10)453840, (01)00880304521247(17)221103(10)477550, (01)00880304521247(17)221102(10)477580, (01)00880304521247(17)221103(10)477590, (01)00880304521247(17)221103(10)547510, (01)00880304521247(17)221109(10)438360, (01)00880304521247(17)221109(10)438420, (01)00880304521247(17)221102(10)453810, (01)00880304521247(17)221103(10)453850, (01)00880304521247(17)221111(10)477570, (01)00880304521247(17)221111(10)477600, (01)00880304521247(17)221108(10)547520, (01)00880304521247(17)221111(10)784740, (01)00880304521247(17)221121(10)438280, (01)00880304521247(17)221117(10)438320, (01)00880304521247(17)221117(10)438380, (01)00880304521247(17)221120(10)547470, (01)00880304521247(17)221125(10)561190, (01)00880304521247(17)221103(10)547490, (01)00880304521247(17)221213(10)453750, (01)00880304521247(17)221216(10)946070, (01)00880304521247(17)221229(10)164130, (01)00880304521247(17)230102(10)453780, (01)00880304521247(17)230111(10)164140, (01)00880304521247(17)230116(10)431330, (01)00880304521247(17)210209(10)683120R, (01)00880304521247(17)230312(10)034680, (01)00880304521247(17)230311(10)950380, (01)00880304521247(17)230312(10)988870, (01)00880304521247(17)230319(10)618540, (01)00880304521247(17)230319(10)875430, (01)00880304521247(17)230320(10)988910, (01)00880304521247(17)230416(10)275310, (01)00880304521247(17)230417(10)303400, (01)00880304521247(17)230417(10)736780, (01)00880304521247(17)230423(10)143600, (01)00880304521247(17)221115(10)438220, (01)00880304521247(17)230423(10)438430, (01)00880304521247(17)230502(10)934880, (01)00880304521247(17)230502(10)935040, (01)00880304521247(17)230521(10)042490, (01)00880304521247(17)221213(10)453750R, (01)00880304521247(17)201118(10)770970R, (01)00880304521247(17)240501(10)518530, (01)00880304521247(17)240501(10)478470, (01)00880304521247(17)240503(10)478480, (01)00880304521247(17)240503(10)478500, (01)00880304521247(17)240501(10)518520, (01)00880304521247(17)240502(10)518540, (01)00880304521247(17)240513(10)261860, (01)00880304521247(17)240513(10)518500, (01)00880304521247(17)240512(10)639250, (01)00880304521247(17)240513(10)639280, (01)00880304521247(17)240512(10)639310, (01)00880304521247(17)240513(10)639350, (01)00880304521247(17)240512(10)639370, (01)00880304521247(17)240512(10)639380, (01)00880304521247(17)240515(10)639240, (01)00880304521247(17)240515(10)639270, (01)00880304521247(17)240515(10)639340, (01)00880304521247(17)240516(10)662040, (01)00880304521247(17)240516(10)662060, (01)00880304521247(17)240525(10)518510, (01)00880304521247(17)240526(10)778040, (01)00880304521247(17)240607(10)518490, (01)00880304521247(17)240609(10)662080, (01)00880304521247(17)240515(10)261870, (01)00880304521247(17)240628(10)403980, (01)00880304521247(17)240601(10)662050, (01)00880304521247(17)240611(10)717850, (01)00880304521247(17)240802(10)742340, (01)00880304521247(17)240526(10)777310, (01)00880304521247(17)240528(10)777330, (01)00880304521247(17)240702(10)777340, (01)00880304521247(17)240622(10)777380, (01)00880304521247(17)240528(10)778100, (01)00880304521247(17)240612(10)812880, (01)00880304521247(17)240802(10)812890, (01)00880304521247(17)240615(10)813510, (01)00880304521247(17)240611(10)813530, (01)00880304521247(17)240622(10)845400, (01)00880304521247(17)240620(10)845420, (01)00880304521247(17)240620(10)845440, (01)00880304521247(17)240801(10)845450, (01)00880304521247(17)240622(10)845470, (01)00880304521247(17)240620(10)845480, (01)00880304521247(17)240617(10)877510, (01)00880304521247(17)240614(10)877530, (01)00880304521247(17)240805(10)518470, (01)00880304521247(17)240816(10)063800, (01)00880304521247(17)200917(10)092510R, (01)00880304521247(17)200707(10)374910R, (01)00880304521247(17)240828(10)063790, (01)00880304521247(17)240828(10)063810, (01)00880304521247(17)240828(10)210670, (01)00880304521247(17)240828(10)210690, (01)00880304521247(17)240927(10)639300, (01)00880304521247(17)240926(10)777250, (01)00880304521247(17)240926(10)788250, (01)00880304521247(17)240927(10)788430, (01)00880304521247(17)240927(10)807220, (01)00880304521247(17)241003(10)788200, (01)00880304521247(17)241003(10)788420, (01)00880304521247(17)241003(10)806950, (01)00880304521247(17)241003(10)806960, (01)00880304521247(17)241003(10)807210, (01)00880304521247(17)241003(10)894160, (01)00880304521247(17)241010(10)028970, (01)00880304521247(17)241010(10)029010, (01)00880304521247(17)241010(10)029020, (01)00880304521247(17)241009(10)807200, (01)00880304521247(17)241008(10)894150, (01)00880304521247(17)241022(10)331320, (01)00880304521247(17)241023(10)330960, (01)00880304521247(17)221109(10)438360R, (01)00880304521247(17)241110(10)465390, (01)00880304521247(17)241110(10)465400, (01)00880304521247(17)241110(10)503380, (01)00880304521247(17)241108(10)503450, (01)00880304521247(17)241107(10)503850, (01)00880304521247(17)241119(10)641640, (01)00880304521247(17)241119(10)641670, (01)00880304521247(17)241206(10)689810, (01)00880304521247(17)241206(10)689820, (01)00880304521247(17)241208(10)689830, (01)00880304521247(17)241208(10)723480, (01)00880304521247(17)241209(10)723490, (01)00880304521247(17)241208(10)723500, (01)00880304521247(17)241208(10)723530, (01)00880304521247(17)241217(10)834840, (01)00880304521247(17)241218(10)834860, (01)00880304521247(17)241217(10)865820, (01)00880304521247(17)241218(10)865840, (01)00880304521247(17)241218(10)834830, (01)00880304521247(17)241218(10)834850, (01)00880304521247(17)241218(10)865810, (01)00880304521247(17)250102(10)723540, (01)00880304521247(17)250102(10)865800, (01)00880304521247(17)241217(10)865830, (01)00880304521247(17)250111(10)910070, (01)00880304521247(17)250113(10)910080, (01)00880304521247(17)250122(10)002410, (01)00880304521247(17)250121(10)946770, (01)00880304521247(17)250121(10)946780, (01)00880304521247(17)250122(10)946790, (01)00880304521247(17)250122(10)946800 (01)00880304521247(17)250121(10)946820
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1645-2020
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.