BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Knee Tibial Cement Spacer Mold (65 MM, Silicone, Sterile, Item 433165) due to potentially insufficient cleaning processes or inadequate process monitoring for cleaning parameters. The product was distributed worldwide and to most U.S. states, with affected lot numbers ranging from 410520 through 361 (the complete list of lot numbers is provided in the recall notice).
The recall record does not specify a remedy or what consumers should do in response to this recall.
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*** 410520, 959170, 036440, 036450, 036460, 095920, 096370, 318810, 527340 527350, 527360, 528040, 600450, 600530, 688350, 729320, 793180, 857860, 977000, 074660, 074670, 145260, 145270, 145330, 239330, 239340, 239440, 496440, 496450, 496580, 680310, 680320, 749140, 729340, 757950, 821960, 821970, 821980, 926370, 025710, 099750, 165730, 247440, 247460, 247470, 352320, 436890, 436900, 459580, 490080, 490090, 562930, 586710, 632840, 632860, 632870, 708730, 708740, 772900, 969280, 996860, 996900, 010220, 051850, 413420, 413460, 242880, 413430, 413440, 413450, 461670, 518850, 583920, 583930, 667480, 667490, 822040, 056570, 156180, 220730, 270120, 270130, 411640, 411650, 434470, 525320, 525330, 540610, 540620, 634030, 688990, 722580, 738690, 823830, 823880, 823890, 970920, 970930, 070910, 070920, 108360, 207280, 257310, 339530, 413190, 548530, 548540, 588810, 643420, 643450, 672470, 706600, 706610, 907660, 976580, 225810, 225890, 274130, 281770, 281790, 369020, 512310, 512250, 579860, 579870, 625620, 625630, 659470, 659480, 731760, 789370, 789380, 003780, 003790, 270940, 270930, 270950, 281120, 281130, 281150, 281140, 392930, 393010, 393020, 281160, 458250, 535710, 535780, 617630, 617730, 617740, 863660, 863670, 863680, 993800, 993880, 993890, 089310, 089320, 232380, 232390, 958710, 492550, 492560, 492570, 492580, 569610, 739050, 745870, 845120, 900860, 738970, 046350, 981530, 981540, 981470, 212260, 212270, 126180, 126300, 126310, 212150, 361160, 412970, 412980, 361
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.