Biomet, Inc.: BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

Is my product affected?

BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

• UPC 00880304002661

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

What happened

Biomet, Inc. is recalling the BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile (Item 433170) 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 nearly all U.S. states. The affected products are identified by specific lot numbers ranging from 809860 through 90.

The record does not specify a remedy or instructions for what affected consumers should do.

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*** 809860, 273440, 449670, 036470, 095940, 096460, 959200, 095930, 242330, 242370, 242380, 527370, 527380, 527390, 527400, 528050, 600460, 600540, 688360, 688410, 729340, 793190, 857870, 864610, 977010, 074680, 074690, 074700, 074800, 239360, 239370, 239450, 310130, 367720, 496460, 496470, 496590, 496600, 680330, 680340, 729350, 729360, 791590, 791600, 821990, 844550, 935790, 085550, 152260, 247480, 247490, 286760, 324080, 352330, 425640, 425650, 478220, 478230, 545200, 562940, 613890, 667650, 667670, 698810, 698820, 708750, 772910, 074110, 074120, 123170, 123180, 152790, 215690, 215730, 264980, 310460, 330920, 359680, 393080, 428840, 486280, 486290, 518860, 570270, 570280, 570290, 627900, 627910, 627920, 156190, 156200, 270140, 411660, 434480, 434490, 450660, 489560, 553380, 567590, 567610, 620050, 634080, 738670, 823850, 868850, 942680, 942690, 041310, 041340, 108340, 108350, 171410, 207290, 257320, 548550, 548560, 548570, 548580, 588800, 643460, 643470, 672490, 672500, 789430, 893870, 990190, 058150, 097320, 182030, 241360, 274210, 281780, 325510, 452270, 452280, 512270, 579890, 579900, 625650, 643590, 659490, 659500, 731770, 789400, 789390, 858290, 270960, 270970, 270990, 270980, 281170, 281180, 281210, 281220, 281230, 281200, 392940, 393030, 393040, 458260, 458270, 535720, 535790, 617640, 617750, 617760, 863700, 863710, 863690, 863720, 993810, 993820, 993900, 089330, 232410, 232350, 232400, 492600, 492610, 492590, 569620, 739060, 739070, 738990, 738980, 90

Source

Official record: FDA (Device enforcement) ↗

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

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