Biomet, Inc.: BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

Is my product affected?

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

• UPC 00880304001183

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

What happened

Biomet, Inc. is recalling approximately 230,001 units of the BIOMET StageOne Knee Femoral Cement Spacer Mold (65 MM, Silicone, Sterile, Item 432165) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The recalled devices were distributed worldwide and to numerous U.S. states including Alaska, California, Florida, Texas, New York, and many others.

The recall affects specific lot numbers identified in the distribution record. According to the source document, no remedy is specified for this recall.

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*** 410380, 036380, 095880, 095890, 095900, 096130, 096260, 096310, 096340, 096280, 242320, 242340, 242360, 318790, 527250, 527260, 527950, 527240, 527970, 527990, 688310, 793170, 857820, 857830, 864580, 864600, 864590, 976940, 976950, 977160, 074620, 074630, 074760, 310210, 145230, 239240, 239260, 239270, 239410, 239420, 310070, 310080, 310240, 310250, 367690, 496540, 496550, 496400, 680280, 680400, 680410, 702460, 702470, 749110, 749120, 791550, 791560, 844530, 902650, 914080, 025500, 085540, 136890, 219930, 219940, 272150, 272160, 272170, 324060, 413090, 413100, 413110, 459570, 478200, 518450, 545170, 562920, 601550, 613880, 667610, 685330, 685340, 685350, 747290, 772890, 898010, 910630, 945840, 969600, 985840, 123080, 123130, 123140, 139790, 139800, 139820, 201140, 242900, 242910, 310430, 330890, 330900, 413410, 447710, 447720, 461660, 486270, 499290, 518840, 802360, 802390, 899180, 090910, 156140, 252780, 252790, 998620, 411590, 434420, 434430, 450640, 509780, 567550, 567560, 620030, 634070, 722570, 722650, 722660, 803110, 803120, 898740, 942670, 007840, 007850, 108320, 108330, 171400, 237760, 257300, 372780, 372790, 428280, 428290, 548510, 588770, 628650, 628720, 628730, 689320, 689310, 771080, 874740, 990090, 058090, 058110, 097290, 132530, 225900, 274180, 274190, 325480, 325470, 339730, 411260, 425150, 579820, 579810, 625560, 625580, 659420, 659430, 659440, 731740, 789340, 789350, 858270, 904770, 270830, 270840, 270850, 270860, 270870, 281000, 281030, 28

Source

Official record: FDA (Device enforcement) ↗

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

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