Biomet, Inc.: BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

Is my product affected?

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

• UPC 00880304001176

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling the BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile (Item 432175) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Approximately 230,001 units were distributed worldwide, including distribution to numerous U.S. states. The recall affects specific lot numbers, which are listed in the recall record.

The recall source does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Details from the source

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*** 593990, 240410, 417130, 893160, 959150, 527310, 527330, 527320, 600520, 688340, 729310, 976980, 976990, 145250, 239320, 310120, 496420, 496430, 680300, 757940, 791580, 830280, 978080, 107640, 260580, 390560, 390570, 436970, 586690, 586700, 698800, 871250, 871260, 871270, 910920, 088360, 074100, 215500, 242860, 310440, 381750, 555620, 555630, 695540, 783280, 156170, 411620, 411630, 489600, 567470, 634040, 789380, 722610, 007780, 070930, 207270, 356340, 428250, 588730, 658370, 789420, 874750, 058080, 168510, 274140, 325430, 452250, 543120, 610640, 659380, 745490, 003770, 281100, 281110, 392870, 392960, 458240, 535750, 617660, 863650, 863630, 863640, 089300, 232450, 632660, 492530, 492540, 845110, 745860, 981500, 046280, 126240, 212190, 314660, 361130, 361140, 470650, 807180, 866170, 866260, 866300, 131830, 131850, 178030, 225990, 520650, 520660, 611540, 776850, 788270, 046020, 166190, 317630, 317640, 525840, 525940, 697720, 836030, 923060, 047060, 210250, 210110, 351620, 500810, 555030, 771000, 839180, 839230, 955890, 238290, 238300, 238280, 238530, 783070, 783110, 903240, 903250, 225850, 225860, 225870, 225880, 735120, 735130, 735100, 735110, 583100, 583110, 583080, 583090, 598860, 598870, 655000, 655010, 655080, 655090, 655100, 655110, 655130, 655140, 655160, 655170, 655180, 655190, 598880, 790350, 790380, 790410, 790460, 861860, 790260, 861850, 790270, 790340, 992620, 202710, 202730, 521190, 521210, 521220, 521230, 521140, 521150, 521160, 521170, 521180, 31

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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