BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile (Item 431182) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected products were distributed worldwide and to numerous U.S. states, encompassing numerous lot numbers and UDI numbers.
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*** 572290, 961940, 769090, 961950, 982370, 321690, 623220, 636030, 853960, 050730, 050740, 082030, 020960, 201900, 234210, 392780, 556600, 846260, 171620, 401240, 382920, 090430, 474060, 353200, 419290, 474070, 271550, 280100, 009830, 758570, 009810, 063980, 431240, 913700, 940270, 251360, 470170, 990110, 229340, 858190, 790240, 790250, 295180, 679730, 679720, 048450, 952900, 853130, 931890, 931900, 716130, 496490, 152510, 313800, 390440, 496470, 496510, 937100, 972200, 362290, 362270, 362280, 528960, 676860, 676890, 676960, 677030, 966930, 966940, 184470, 829810, 949750, 949760, 184460, 591250, 591240, 988930, 988940, 558090, 251360R, 827050, 827030, 827070, 892630, 892670, 893780, 893810, 893820, 892680, 893800, 229540, 778270, 893750, 628530, 628540, 778280, 628550, 618570, 618580, 618590, 884510, 747430, 827850, 884520, 827010, 893800R, 455690, 455770, 455780, 455760, 478940, 478900, 569610, 570060, 477280, 478790, 455720, 455730, 476940, 477030, 477080, 477100, 477120, 477130, 477220, 478810, 478880, 478890, 478920, 478930, 568920, 568950, 568960, 568970, 568980, 569000, 569030, 569050, 569540, 569560, 569570, 569590, 569640, 569700, 569780, 569820, 569850, 570000, 570030, 570070, 570090, 570110, 569260, 672780, 737430, 737440, 737460, 226440, 226460, 226470, 478860, 694970, 672020, 672030, 672010, 737540. ***UDI Numbers*** (01)00880304521032(17)170428(10)572290, (01)00880304521032(17)171206(10)961940, (01)00880304521032(17)171207(10)769090, (01)0088030452
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.