BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 BIOMET StageOne Select Hip Stem Cement Spacer Molds (9 X 125 MM, silicone, sterile) distributed worldwide and to numerous U.S. states due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The recalled product is identified by specific lot numbers listed in the recall notice.
The record 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*** 502050, 628160, 754710, 795480, 383860, 938730, 258280, 258190, 520980, 794470, 135080, 407080, 474100, 333620, 576720, 739510, 789340, 949520, 062820, 233420, 348160, 341200, 554920, 750800, 914960, 914980, 117230, 127860, 167340, 551760, 135720, 135760, 135770, 584700, 266500, 266520, 817710, 817680, 462720, 549240, 549340, 462600, 588980, 962650, 048960, 052030, 462420, 462470, 462500, 846510, 846550, 846660, 061800, 353690, 353770, 353730, 353790, 739210, 816110, 816220, 374890, 374880, 654990, 655000, 655010, 792120, 803200, 733600, 792110, 980400, 092160, 118970, 205620, 364700, 756370, 760140, 771060, 771070, 771080, 745790, 770910, 770920, 045110, 063710, 332900, 774490, 774480, 966970, 966990, 017840, 017580, 152210, 912450, 624130, 624140, 665090, 396720, 396730, 418450, 418460, 777400, 777430, 996050, 996060, 996070, 353770R, 092160R, 374890R, 654990R, 418460R, 810910, 864940, 864970, 777670, 906710, 996060R, 115970, 864960, 116000, 116020, 232620, 201250, 201280, 232550, 545970, 996050R, 232590, 232610, 201270, 201300, 269250, 269270, 269280, 269290, 269300, 269320, 269260, 269310, 201290, 401150, 401170, 401200, 888220, 875400, 988830, 034500, 848610, 256590, 377770, 495000, 275070, 377780, 766090, 942270, 942440, 916800, 916830, 942280, 942430, 777670R, 477940, 478080, 478180, 478200, 518250, 518260, 518290, 478150, 518240, 518280, 518310, 276800, 355820, 661780, 661790, 661800, 661880, 661740, 661860, 765320, 812830, 403850, 404010, 404050, 44
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.