BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 473150, 147200, 668750, 668810, 235310, 235260, 565730, 565740, 565780, 565800, 565750, 230020, 096010, 096030, 095830, 688290, 688390, 688400, 976900, 977070, 977080, 239190, 239390, 310050, 310180, 310200, 757930, 978060, 107630, 219920, 260550, 436940, 572340, 572350, 718010, 910910, 996970, 139640, 215600, 447340, 518820, 712320, 270170, 411560, 525340, 619980, 789360, 983800, 207230, 356350, 600710, 658360, 804860, 115880, 274120, 411240, 512260, 610620, 719040, 039580, 735560, 735570, 160950, 628310, 627970, 628320, 628330, 711810, 711820, 765470, 284700, 284710, 488480, 488490, 488500, 051450, 051460, 051470, 051480, 051490, 051500, 162780, 607690, 607700, 722770, 723210, 038660, 038670, 428720, 647320, 647330, 774580, 428700, 994880, 229280, 229290, 740300, 740310, 935460, 935480, 241700, 241820, 409670, 409680, 521740, 521750, 417820, 417840, 417830, 513610, 235260R, 737800, 737810, 755040, 756770, 754990, 755010, 755030, 755060, 755100, 755110, 756790, 756810, 756820, 756830, 756840, 756870, 202430, 202450, 737790, 756850, 520170, 520180, 520190, 310180R, 705570, 705580, 732030, 668750R, 118140, 658600R, 378140, 378130, 378150, 378160, 378170, 520940, 765900, 765920, 765960, 766390, 766420, 766740, 766750, 765890, 766760, 520920, 765880, 765930, 765970, 043400, 043410, 043430, 043450, 043470, 765950, 310200R, 147210R, 409680R, 348050, 347610, 348010, 348020, 348030, 348040, 347660, 318550, 318600, 318640, 318760, 318770, 318820, 318840, 318560, 318580, 318590, 318610, 318810, 337410, 350260, 337370, 337430, 350300, 350310, 337390, 350330, 383540, 383560, 383580, 383590, 318620, 337450, 350290, 350320, 383570, 337380, 337420, 350270, 383550, 449980, 449990, 337400, 450030, 737800R, 754990R, 756820R, 756840R, 378130R, 241820R,***UDI Numbers*** (01)00880304447141(17)191028(10)411170, (01)00880304447141(17)191228(10)928060, (01)00880304447141(17)200228(10)453050, (01)00880304447141(17)200801(10)008400, (01)00880304447141(17)200828(10)008780, (01)00880304447141(17)200928(10)162230, (01)00880304447141(17)201128(10)160450, (01)00880304447141(17)201128(10)160460, (01)00880304447141(17)201128(10)160470, (01)00880304447141(17)210301(10)078140, (01)00880304447141(17)210328(10)212600, (01)00880304447141(17)210428(10)473150, (01)00880304447141(17)210728(10)147200, (01)00880304447141(17)210928(10)668750, (01)00880304447141(17)210928(10)668810, (01)00880304447141(17)211128(10)235310, (01)00880304447141(17)211128(10)235260, (01)00880304447141(17)220128(10)565730, (01)00880304447141(17)220128(10)565740, (01)00880304447141(17)220128(10)565780, (01)00880304447141(17)220128(10)565800, (01)00880304447141(17)220128(10)565750, (01)00880304447141(17)220928(10)230020, (01)00880304447141(17)221206(10)096010, (01)00880304447141(17)221206(10)096030, (01)00880304447141(17)221210(10)095830, (01)00880304447141(17)230213(10)688290, (01)00880304447141(17)230213(10)688390, (01)00880304447141(17)230215(10)688400, (01)00880304447141(17)230314(10)976900, (01)00880304447141(17)230312(10)977070, (01)00880304447141(17)230312(10)977080, (01)00880304447141(17)230424(10)239190, (01)00880304447141(17)230423(10)239390, (01)00880304447141(17)230423(10)310050, (01)00880304447141(17)230422(10)310180, (01)00880304447141(17)230422(10)310200, (01)00880304447141(17)230614(10)757930, (01)00880304447141(17)230715(10)978060, (01)00880304447141(17)230730(10)107630, (01)00880304447141(17)230808(10)219920, (01)00880304447141(17)230814(10)260550, (01)00880304447141(17)230826(10)436940, (01)00880304447141(17)230917(10)572340, (01)00880304447141(17)230916(10)572350, (01)00880304447141(17)230927(10)718010, (01)00880304447141(17)231016(10)910910, (01)00880304447141(17)231025(10)996970, (01)00880304447141(17)231107(10)139640, (01)00880304447141(17)231108(10)215600, (01)00880304447141(17)231202(10)447340, (01)00880304447141(17)231210(10)518820, (01)00880304447141(17)240108(10)712320, (01)00880304447141(17)240226(10)270170, (01)00880304447141(17)240304(10)411560, (01)00880304447141(17)240317(10)525340, (01)00880304447141(17)240328(10)619980, (01)00880304447141(17)240408(10)789360, (01)00880304447141(17)240428(10)983800, (01)00880304447141(17)240518(10)207230, (01)00880304447141(17)240602(10)356350, (01)00880304447141(17)240615(10)600710, (01)00880304447141(17)240622(10)658360, (01)00880304447141(17)240709(10)804860, (01)00880304447141(17)240730(10)115880, (01)00880304447141(17)240813(10)274120, (01)00880304447141(17)240825(10)411240, (01)00880304447141(17)240904(10)512260, (01)00880304447141(17)240911(10)610620, (01)00880304447141(17)240919(10)719040, (01)00880304447141(17)241016(10)039580, (01)00880304447141(17)241216(10)735560, (01)00880304447141(17)241222(10)735570, (01)00880304447141(17)250203(10)160950, (01)00880304447141(17)250324(10)628310, (01)00880304447141(17)250325(10)627970, (01)00880304447141(17)250327(10)628320, (01)00880304447141(17)250329(10)628330, (01)00880304447141(17)250330(10)711810, (01)00880304447141(17)250402(10)711820, (01)00880304447141(17)250410(10)765470, (01)00880304447141(17)250526(10)284700, (01)00880304447141(17)250527(10)284710, (01)00880304447141(17)250615(10)488480, (01)00880304447141(17)250615(10)488490, (01)00880304447141(17)250612(10)488500, (01)00880304447141(17)250811(10)051450, (01)00880304447141(17)250807(10)051460, (01)00880304447141(17)250807(10)051470, (01)00880304447141(17)250811(10)051480, (01)00880304447141(17)250811(10)051490, (01)00880304447141(17)250811(10)051500, (01)00880304447141(17)250824(10)162780, (01)00880304447141(17)251001(10)607690, (01)00880304447141(17)251001(10)607700, (01)00880304447141(17)251013(10)722770, (01)00880304447141(17)251013(10)723210, (01)00880304447141(17)251110(10)038660, (01)00880304447141(17)251110(10)038670, (01)00880304447141(17)251217(10)428720, (01)00880304447141(17)260107(10)647320, (01)00880304447141(17)260107(10)647330, (01)00880304447141(17)260119(10)774580, (01)00880304447141(17)260126(10)428700, (01)00880304447141(17)260203(10)994880, (01)00880304447141(17)260301(10)229280, (01)00880304447141(17)260301(10)229290, (01)00880304447141(17)260407(10)740300, (01)00880304447141(17)260408(10)740310, (01)00880304447141(17)260421(10)935460, (01)00880304447141(17)260422(10)935480, (01)00880304447141(17)260517(10)241700, (01)00880304447141(17)260517(10)241820, (01)00880304447141(17)260607(10)409670, (01)00880304447141(17)260607(10)409680, (01)00880304447141(17)260613(10)521740, (01)00880304447141(17)260615(10)521750, (01)00880304447141(17)260824(10)417820, (01)00880304447141(17)260824(10)417840, (01)00880304447141(17)260824(10)417830, (01)00880304447141(17)260916(10)513610, (01)00880304447141(17)211101(10)235260R, (01)00880304447141(17)270617(10)737800, (01)00880304447141(17)270616(10)737810, (01)00880304447141(17)270616(10)755040, (01)00880304447141(17)270619(10)756770, (01)00880304447141(17)270624(10)754990, (01)00880304447141(17)270623(10)755010, (01)00880304447141(17)270625(10)755030, (01)00880304447141(17)270622(10)755060, (01)00880304447141(17)270622(10)755100, (01)00880304447141(17)270623(10)755110, (01)00880304447141(17)270626(10)756790, (01)00880304447141(17)270626(10)756810, (01)00880304447141(17)270627(10)756820, (01)00880304447141(17)270626(10)756830, (01)00880304447141(17)270626(10)756840, (01)00880304447141(17)270624(10)756870, (01)00880304447141(17)270629(10)202430, (01)00880304447141(17)270629(10)202450, (01)00880304447141(17)270628(10)737790, (01)00880304447141(17)270627(10)756850, (01)00880304447141(17)270728(10)520170, (01)00880304447141(17)270726(10)520180, (01)00880304447141(17)270729(10)520190, (01)00880304447141(17)230422(10)310180R, (01)00880304447141(17)270916(10)705570, (01)00880304447141(17)270916(10)705580, (01)00880304447141(17)270906(10)732030, (01)00880304447141(17)210901(10)668750R, (01)00880304447141(17)271127(10)118140, (01)00880304447141(17)221001(10)658600R, (01)00880304447141(17)280228(10)378140, (01)00880304447141(17)280301(10)378130, (01)00880304447141(17)280301(10)378150, (01)00880304447141(17)280301(10)378160, (01)00880304447141(17)280301(10)378170, (01)00880304447141(17)280328(10)520940, (01)00880304447141(17)280323(10)765900, (01)00880304447141(17)280323(10)765920, (01)00880304447141(17)280328(10)765960, (01)00880304447141(17)280327(10)766390, (01)00880304447141(17)280327(10)766420, (01)00880304447141(17)280328(10)766740, (01)00880304447141(17)280327(10)766750, (01)00880304447141(17)280329(10)765890, (01)00880304447141(17)280328(10)766760, (01)00880304447141(17)280410(10)520920, (01)00880304447141(17)280405(10)765880, (01)00880304447141(17)280403(10)765930, (01)00880304447141(17)280404(10)765970, (01)00880304447141(17)280417(10)043400, (01)00880304447141(17)280420(10)043410, (01)00880304447141(17)280417(10)043430, (01)00880304447141(17)280417(10)043450, (01)00880304447141(17)280420(10)043470, (01)00880304447141(17)280430(10)765950, (01)00880304447141(17)230422(10)310200R, (01)00880304447141(17)210701(10)147210R, (01)00880304447141(17)260607(10)409680R, (01)00880304447141(17)290205(10)348050, (01)00880304447141(17)290211(10)347610, (01)00880304447141(17)290207(10)348010, (01)00880304447141(17)290207(10)348020, (01)00880304447141(17)290207(10)348030, (01)00880304447141(17)290207(10)348040, (01)00880304447141(17)290205(10)347660, (01)00880304447141(17)290402(10)318550, (01)00880304447141(17)290403(10)318600, (01)00880304447141(17)290402(10)318640, (01)00880304447141(17)290402(10)318760, (01)00880304447141(17)290402(10)318770, (01)00880304447141(17)290402(10)318820, (01)00880304447141(17)290402(10)318840, (01)00880304447141(17)290403(10)318560, (01)00880304447141(17)290405(10)318580, (01)00880304447141(17)290405(10)318590, (01)00880304447141(17)290404(10)318610, (01)00880304447141(17)290404(10)318810,, (01)00880304447141(17)290405(10)337410, (01)00880304447141(17)290409(10)350260, (01)00880304447141(17)290409(10)337370, (01)00880304447141(17)290410(10)337430, (01)00880304447141(17)290410(10)350300, (01)00880304447141(17)290410(10)350310, (01)00880304447141(17)290422(10)337390, (01)00880304447141(17)290422(10)350330, (01)00880304447141(17)290422(10)383540, (01)00880304447141(17)290420(10)383560, (01)00880304447141(17)290422(10)383580, (01)00880304447141(17)290421(10)383590, (01)00880304447141(17)290501(10)318620, (01)00880304447141(17)290430(10)337450, (01)00880304447141(17)290430(10)350290, (01)00880304447141(17)290501(10)350320, (01)00880304447141(17)290430(10)383570, (01)00880304447141(17)290502(10)337380, (01)00880304447141(17)290502(10)337420, (01)00880304447141(17)290506(10)350270, (01)00880304447141(17)290506(10)383550, (01)00880304447141(17)290502(10)449980, (01)00880304447141(17)290502(10)449990, (01)00880304447141(17)290518(10)337400, (01)00880304447141(17)290518(10)450030, (01)00880304447141(17)270617(10)737800R, (01)00880304447141(17)270624(10)754990R, (01)00880304447141(17)270627(10)756820R, (01)00880304447141(17)270626(10)756840R, (01)00880304447141(17)280301(10)378130R, (01)00880304447141(17)260517(10)241820R (01)00880304447141(17)230814(10)260550R 260550R.
- 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, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Product Codes/Lot Numbers:
***Lot Numbers*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 473150, 147200, 668750, 668810, 235310, 235260, 565730, 565740, 565780, 565800, 565750, 230020, 096010, 096030, 095830, 688290, 688390, 688400, 976900, 977070, 977080, 239190, 239390, 310050, 310180, 310200, 757930, 978060, 107630, 219920, 260550, 436940, 572340, 572350, 718010, 910910, 996970, 139640, 215600, 447340, 518820, 712320, 270170, 411560, 525340, 619980, 789360, 983800, 207230, 356350, 600710, 658360, 804860, 115880, 274120, 411240, 512260, 610620, 719040, 039580, 735560, 735570, 160950, 628310, 627970, 628320, 628330, 711810, 711820, 765470, 284700, 284710, 488480, 488490, 488500, 051450, 051460, 051470, 051480, 051490, 051500, 162780, 607690, 607700, 722770, 723210, 038660, 038670, 428720, 647320, 647330, 774580, 428700, 994880, 229280, 229290, 740300, 740310, 935460, 935480, 241700, 241820, 409670, 409680, 521740, 521750, 417820, 417840, 417830, 513610, 235260R, 737800, 737810, 755040, 756770, 754990, 755010, 755030, 755060, 755100, 755110, 756790, 756810, 756820, 756830, 756840, 756870, 202430, 202450, 737790, 756850, 520170, 520180, 520190, 310180R, 705570, 705580, 732030, 668750R, 118140, 658600R, 378140, 378130, 378150, 378160, 378170, 520940, 765900, 765920, 765960, 766390, 766420, 766740, 766750, 765890, 766760, 520920, 765880, 765930, 765970, 043400, 043410, 043430, 043450, 043470, 765950, 310200R, 147210R, 409680R, 348050, 347610, 348010, 348020, 348030, 348040, 347660, 318550, 318600, 318640, 318760, 318770, 318820, 318840, 318560, 318580, 318590, 318610, 318810, 337410, 350260, 337370, 337430, 350300, 350310, 337390, 350330, 383540, 383560, 383580, 383590, 318620, 337450, 350290, 350320, 383570, 337380, 337420, 350270, 383550, 449980, 449990, 337400, 450030, 737800R, 754990R, 756820R, 756840R, 378130R, 241820R,***UDI Numbers*** (01)00880304447141(17)191028(10)411170, (01)00880304447141(17)191228(10)928060, 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(01)00880304447141(17)221001(10)658600R, (01)00880304447141(17)280228(10)378140, (01)00880304447141(17)280301(10)378130, (01)00880304447141(17)280301(10)378150, (01)00880304447141(17)280301(10)378160, (01)00880304447141(17)280301(10)378170, (01)00880304447141(17)280328(10)520940, (01)00880304447141(17)280323(10)765900, (01)00880304447141(17)280323(10)765920, (01)00880304447141(17)280328(10)765960, (01)00880304447141(17)280327(10)766390, (01)00880304447141(17)280327(10)766420, (01)00880304447141(17)280328(10)766740, (01)00880304447141(17)280327(10)766750, (01)00880304447141(17)280329(10)765890, (01)00880304447141(17)280328(10)766760, (01)00880304447141(17)280410(10)520920, (01)00880304447141(17)280405(10)765880, (01)00880304447141(17)280403(10)765930, (01)00880304447141(17)280404(10)765970, (01)00880304447141(17)280417(10)043400, (01)00880304447141(17)280420(10)043410, (01)00880304447141(17)280417(10)043430, (01)00880304447141(17)280417(10)043450, (01)00880304447141(17)280420(10)043470, 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(01)00880304447141(17)290409(10)350260, (01)00880304447141(17)290409(10)337370, (01)00880304447141(17)290410(10)337430, (01)00880304447141(17)290410(10)350300, (01)00880304447141(17)290410(10)350310, (01)00880304447141(17)290422(10)337390, (01)00880304447141(17)290422(10)350330, (01)00880304447141(17)290422(10)383540, (01)00880304447141(17)290420(10)383560, (01)00880304447141(17)290422(10)383580, (01)00880304447141(17)290421(10)383590, (01)00880304447141(17)290501(10)318620, (01)00880304447141(17)290430(10)337450, (01)00880304447141(17)290430(10)350290, (01)00880304447141(17)290501(10)350320, (01)00880304447141(17)290430(10)383570, (01)00880304447141(17)290502(10)337380, (01)00880304447141(17)290502(10)337420, (01)00880304447141(17)290506(10)350270, (01)00880304447141(17)290506(10)383550, (01)00880304447141(17)290502(10)449980, (01)00880304447141(17)290502(10)449990, (01)00880304447141(17)290518(10)337400, (01)00880304447141(17)290518(10)450030, (01)00880304447141(17)270617(10)737800R, (01)00880304447141(17)270624(10)754990R, (01)00880304447141(17)270627(10)756820R, (01)00880304447141(17)270626(10)756840R, (01)00880304447141(17)280301(10)378130R, (01)00880304447141(17)260517(10)241820R (01)00880304447141(17)230814(10)260550R 260550R.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1654-2020
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.