BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Knee Tibial Cement Spacer Mold (75 MM, silicone, sterile) distributed worldwide and to multiple U.S. states. The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters affecting the product. The affected units are identified by specific lot numbers, which are listed in the full recall record.
The recall notice does not specify a remedy or corrective 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*** 810230, 273520, 585000, 036490, 095960, 095970, 096440, 096520, 096550, 096570, 527410, 528060, 600550, 688370, 688420, 688430, 688440, 688450, 977020, 977180, 977190, 977200, 977210, 145280, 145340, 145350, 145360, 145370, 496650, 496480, 496610, 496620, 496630, 496640, 680450, 680460, 680470, 680480, 680500, 680520, 680530, 978090, 047800, 165740, 260590, 309970, 390590, 390580, 459590, 459600, 545210, 572360, 572370, 648430, 648440, 708760, 708770, 910940, 910950, 997480, 997490, 087930, 088330, 088350, 264990, 349750, 381760, 428850, 461620, 461630, 555640, 583900, 596850, 712340, 712350, 822020, 822030, 850350, 056580, 220780, 252820, 411670, 411680, 469130, 525350, 553400, 553410, 620000, 722590, 722600, 738700, 898720, 942630, 970950, 970960, 070940, 070950, 339500, 356330, 413200, 428240, 588720, 600750, 628670, 658380, 771060, 804870, 804880, 058070, 168500, 252690, 339710, 339720, 425140, 542740, 597820, 597830, 625660, 659510, 731780, 789410, 904750, 003800, 003810, 280580, 280590, 280600, 280620, 280630, 280640, 280650, 393060, 392950, 458280, 535730, 535740, 535800, 617780, 702380, 863730, 863740, 863750, 863760, 993830, 089210, 089240, 993910, 232430, 232420, 958730, 569660, 569670, 569630, 569650, 845150, 981610, 845130, 845140, 845160, 900890, 981580, 981490, 126230, 126330, 046380, 126220, 212180, 212290, 314730, 361200, 470270, 807290, 807300, 807310, 807260, 807210, 807220, 807240, 807250, 913490, 913400, 047290, 047300, 131930, 226100, 22
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.