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FDAFDA · Food and drugs·Recall number Z-1664-2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

Published April 15, 2020 · Recall initiated: February 26, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Biomet, Inc.
Distributor
Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.
Lot
***Lot Numbers*** 606370, 049930, 959120, 036410, 036420, 095910, 096360, 959140, 318800, 527300, 528020, 527270, 527280, 527290, 528000, 528030, 688320, 688330, 729300, 857840, 976970, 976960, 977170, 074640, 074650, 074770, 239280, 239300, 239430, 310090, 310110, 145240, 239310, 367700, 496560, 496410, 496570, 680290, 702490, 749130, 680440, 702480, 782850, 791570, 844540, 914100, 914120, 033300, 074140, 136900, 219950, 219960, 260570, 272180, 324070, 425620, 425630, 436960, 478210, 545180, 545190, 586680, 667620, 667640, 685360, 685370, 708720, 747310, 074080, 074090, 123160, 139830, 139840, 330910, 349740, 393060, 393070, 499300, 531410, 531420, 596830, 596840, 712330, 802370, 802400, 899190, 013170, 090920, 156150, 156160, 252800, 411600, 411610, 434440, 434450, 450650, 509790, 553370, 567570, 567580, 620040, 722670, 789370, 803140, 803130, 007860, 007870, 041330, 132870, 237790, 237780, 207260, 372800, 428310, 548520, 588790, 628750, 689330, 689340, 628740, 771090, 874730, 893860, 058130, 097310, 225910, 274110, 274200, 325490, 325500, 411270, 452260, 579830, 579850, 625600, 643580, 659450, 659460, 731750, 789360, 858280, 270880, 270890, 270900, 270910, 270920, 281060, 281070, 281090, 281080, 392910, 392990, 393000, 458220, 458210, 535770, 535840, 617720, 617620, 617710, 702370, 863600, 863610, 863620, 863590, 993740, 993790, 567400, 567410, 567360, 567380, 567390, 567340, 567370, 569560, 569600, 739040, 567330, 845090, 845080, 845100, 900850, 046330, 046340, 981460, 126280, 212250, 046240, 046270, 126290, 212120, 212130, 314700, 361110, 361100, 361120, 866180, 866190, 866200, 866210, 866230, 624820, 624840, 866240, 047330, 913350, 913360, 913450, 131880, 131890, 177990, 177980, 226030, 226040, 372290, 372280, 374900, 374910, 455030, 520670, 611570, 679610, 679600, 788250, 788260, 971720, 971690, 046000, 046010, 166170, 166180, 364340, 317620, 317600, 317610, 525750, 525820, 525830, 525930, 697710, 697650, 836020, 835960, 923040, 923050, 922960, 047040, 210230, 210160, 210090, 210100, 440460, 554960, 554970, 554980, 554990, 555000, 555010, 555020, 675010, 675060, 771030, 027690, 027700, 027710, 027720, 109500, 110560, 238740, 238720, 238730, 238750, 347350, 347360, 486390, 486320, 486400, 588200, 783160, 783170, 783090, 783100, 004940, 004960, 932070, 004930, 225900, 225990, 226010, 225890, 432840, 432850, 432860, 432890, 432870, 432880, 557910, 557920, 557940, 557960, 557970, 557980, 558010, 558020, 558030, 558040, 558050, 558060, 598830, 598840, 598850, 654620, 654630, 654640, 654650, 654660, 654670, 654680, 654690, 654700, 654710, 654720, 654730, 790080, 861820, 861840, 861830, 790090, 790100, 790170, 790180, 790200, 790230, 992340, 992350, 992510, 992520, 992610, 992310, 992320, 992370, 992500, 992600, 202550, 202560, 202570, 202580, 202590, 202600, 202610, 202620, 202630, 202660, 992430, 520880, 520910, 520920, 520940, 520950, 520970, 520980, 521000, 521010, 521030, 521050, 521060, 521080, 674490, 633690, 633700, 633710, 633720, 674480, 809170, 809180, 177750, 177770, 177780, 296660, 325730, 325770, 296560, 437630, 618690, 747150, 747090, 747100, 747140, 747290, 916410, 916450, 916420, 916430, 766240, 766470, 766480, 766590, 766230, 766600, 043950, 043960, 044150, 044160, 043930, 043940, 267100, 267110, 267170, 267180, 267190, 460860, 992430R, 294920, 294930, 294950, 294960, 294970, 295000, 295030, 295040, 295050, 295060, 295070, 295080, 320510, 320520, 320540, 320550, 320560, 320570, 294940, 294990, 295010, 295020, 320530, 320580, 699490, 699500, 699510, 709630, 709640, 709870, 70
Risk classification
Class II
Area (FDA)
device
Country
United States

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