BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Knee Femoral Cement Spacer Mold (60 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The recalled products were distributed worldwide and in the United States to 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, and Nevada. The recall affects numerous lot numbers beginning with codes such as 584770, 095850, 095860, and many others.
The recall document does not specify a remedy or recommended action 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*** 584770, 095850, 095860, 095870, 096040, 096050, 096060, 096070, 096090, 096100, 096110, 095840, 096080, 318760, 527220, 527230, 600510, 688300, 793160, 857810, 976910, 976920, 976930, 977090, 977120, 977140, 074610, 239220, 074780, 239230, 310060, 367680, 496380, 496390, 496530, 680250, 702440, 702450, 782830, 782840, 791540, 830290, 830300, 926390, 136880, 177480, 247430, 272140, 309960, 413070, 425610, 459560, 478190, 545150, 545160, 586670, 613870, 667590, 667600, 685310, 685320, 772880, 969470, 010200, 010210, 088220, 170070, 242890, 294830, 330870, 330880, 428820, 428830, 447500, 461650, 499260, 531400, 555660, 596820, 899170, 090900, 156130, 252760, 252770, 411570, 411580, 434390, 434400, 434410, 509760, 509770, 567540, 567530, 620020, 722630, 722640, 803100, 898730, 942660, 007820, 007830, 108310, 132860, 171390, 257290, 428210, 548490, 548500, 588740, 628700, 628710, 689300, 771070, 907630, 907670, 097280, 274100, 274170, 325460, 369000, 411250, 579780, 579790, 625540, 643570, 659400, 659410, 731730, 745520, 745530, 858340, 270810, 270820, 280950, 280960, 280970, 280980, 280990, 392970, 392890, 458180, 535670, 535760, 615720, 617670, 617680, 702350, 863530, 863540, 993760, 993850, 993750, 089250, 232340, 232360, 958700, 492450, 492460, 492470, 569520, 569530, 738940, 739010, 745850, 845060, 900820, 981510, 046290, 046300, 981430, 126260, 212220, 126250, 212080, 212200, 314670, 361070, 731540, 731550, 731560, 731570, 731580, 807270, 807200, 866310, 91
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.