BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
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 (48 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected product was distributed worldwide and to numerous U.S. states. The recall involves specific lot numbers and UDI numbers identified in the record.
The record does not specify a remedy or recommended action for consumers who may have obtained this product.
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*** 623210, 636020, 822620, 865060, 823110, 922950, 234200, 556590, 801160, 919620, 115650, 401230, 382910, 508910, 189900, 534730, 009800, 280090, 844520, 297620, 554620, 744820, 431230, 913690, 940260, 745380, 981490, 251350, 364310, 675220, 940100, 990100, 327990, 396630, 903720, 295160, 374220, 679700, 679710, 716140, 952890, 496420, 496430, 820430, 816090, 921260, 496440, 496460, 038620, 292650, 441830, 362260, 683620, 966920, 829800, 949730, 591230, 988900, 988910, 826960, 757380, 988910R, 229040, 757370, 757390, 757400, 826970, 893670, 826990, 757410, 826930, 893720, 893710, 808600, 778290, 915190, 808580, 884480, 884490, 920520, 920530, 920540, 920530R, 455880, 455900, 696930, 737370, 737380, 455910, 569270, 569280, 569290, 569300, 569320, 569330, 569340, 569360, 569370, 569380, 696800, 696820, 696830, 696840, 696850, 696860, 696890, 696900, 696910, 765040, 765050, 765060, 765070, 765080, 672450, 672460, 672640, 672650, 672770, 737700, 672480, 696920, 694950, 694960, 671920, 672000. ***UDI Numbers*** (01)00880304521100(17)180220(10)623210, (01)00880304521100(17)180221(10)636020, (01)00880304521100(17)180307(10)822620, (01)00880304521100(17)180308(10)865060, (01)00880304521100(17)180313(10)823110, (01)00880304521100(17)180320(10)922950, (01)00880304521100(17)180503(10)234200, (01)00880304521100(17)180628(10)556590, (01)00880304521100(17)180724(10)801160, (01)00880304521100(17)180808(10)919620, (01)00880304521100(17)180819(10)115650, (01)00880304521100(17)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.