BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. has recalled approximately 230,001 units of the BIOMET StageOne Knee Tibial Cement Spacer Mold (80 MM, Silicone, Sterile, Item 433180) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The product was distributed worldwide and to numerous U.S. states. The recalled units span numerous lot numbers, and affected consumers can identify whether they have a recalled product by checking their lot number against the extensive list provided in the recall notice.
The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Distribution: 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, Nev Quantity: 230,001 Lot/code info: ***Lot Numbers*** 164050, 200280, 200310, 792540, 417400, 768490, 907050, 036500, 318820, 527430, 527420, 600560, 600570, 793200, 857880, 977030, 074710, 145290, 239380, 367730, 496490, 496500, 702500, 757960, 791610, 954460, 025760, 165750, 286790, 352340, 436910, 562950, 648450, 708780, 772920, 834070, 910840, 187220, 187730, 265000, 359710, 531380, 627930, 667500, 627940, 628010, 013140, 140060, 013180, 220750, 411690, 411700, 469140, 540630, 604560, 689000, 789400, 823840, 970940, 339470, 356320, 372740, 483860, 643480, 643490, 706580, 789470, 976620, 325370, 325380, 325390, 397400, 579910, 579920, 579930, 625680, 003830, 904720, 904730, 271000, 281240, 281250, 393050, 392880, 458290, 617770, 617650, 615790, 863770, 993840, 993920, 232440, 492620, 492630, 569680, 739000, 981590, 046390, 126340, 126200, 212300, 314740, 412930, 412940, 413010, 550280, 807330, 913510, 866250, 047310, 178020, 226110, 316470, 428550, 428580, 455020, 611610, 788330, 166250, 317740, 364300, 525890, 697770, 697620, 836100, 047150, 047160, 047170, 210210, 351740, 351650, 501030, 555130, 771020, 771060, 806850, 955990, 238970, 239020, 239070, 486450, 783200, 783150, 903280, 932080, 374610, 374580, 374590, 374600, 892000, 892390, 892020, 892040, 892430, 930920, 930930, 930940, 930950, 930990, 931020, 973290, 973300, 973320, 014840, 014850, 014860, 014870, 022580, 022600, 022610, 022620, 025290, 973310, 203010, 203020, 203050, 203060, 203070, 203080, 524270, 524250, 524280, 524310, 524320, 524340, 52
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.