BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling the BIOMET StageOne Select Hip Stem Cement Spacer Mold (11 X 135 MM, Silicone, Sterile, Item 431191) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. A total of 230,001 units were distributed worldwide, including distribution across numerous U.S. states. The affected products are identified by specific lot numbers, ranging from lot 996010 through lot 63963.
The source document does not specify a remedy or what action affected consumers should take.
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*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500, 453510, 546840, 546880, 547080, 940920, 437500, 437530, 477540, 546870, 974080, 105570, 226490, 547090, 071960, 105390, 799100R, 071940, 105470, 105550, 105460, 105480, 105510, 105520, 105430, 295490, 295500, 431310, 712100, 808020, 950370, 808030, 295470, 988850, 143520, 497700, 916880, 917200, 431520, 437530R, 478430, 478260, 478280, 478300, 478330, 478370, 478450, 518400, 518410, 518450, 518460, 478220, 570450, 639600, 639620, 639660, 639680, 639690, 644470, 661920, 661930, 661950, 662000, 261760, 261790, 276830, 661960, 661970, 661980, 662020, 518350, 661940, 696960, 696990, 455030, 570430, 63963
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.