Biomet, Inc.: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

Is my product affected?

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

• UPC 00880304521155

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

What happened

Biomet, Inc. has recalled approximately 230,001 units of BIOMET StageOne Select Hip Stem Cement Spacer Mold (17 X 165 MM, silicone, sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected products were distributed worldwide, including to all U.S. states. The recall involves numerous lot numbers and corresponding UDI numbers spanning manufacturing dates from June 2016 through at least early 2019.

The recall record does not specify a remedy or corrective 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*** 978860, 087790, 087800, 157940, 558560, 564460, 052410, 052420, 052430, 052470, 052480, 230620, 230650, 575290, 767190, 766930, 789110, 031190, 031210, 031320, 265710, 349900, 654570, 927670, 767300, 817690, 188780, 188790, 932920, 205930, 429810, 655510, 092640, 757250, 771000, 683180, 803570, 217230, 197360, 291810, 799130, 552560, 974130, 249280, 249290, 233870, 188790R, 547700, 116180, 071090, 071100, 116160, 784730, 946240, 767190R, 487340, 552590, 655510R, 431450, 617650, 617770, 736810, 988930, 934780, 920630, 092640R, 552560R, 799130R, 920630R, 233870R, 291810R. ***UDI Numbers*** (01)00880304521155(17)160628(10)978860, (01)00880304521155(17)160728(10)087790, (01)00880304521155(17)160728(10)087800, (01)00880304521155(17)160728(10)157940, (01)00880304521155(17)160831(10)558560, (01)00880304521155(17)160928(10)564460, (01)00880304521155(17)170228(10)052410, (01)00880304521155(17)170228(10)052420, (01)00880304521155(17)170228(10)052430, (01)00880304521155(17)170228(10)052470, (01)00880304521155(17)170228(10)052480, (01)00880304521155(17)180108(10)230620, (01)00880304521155(17)180108(10)230650, (01)00880304521155(17)180215(10)575290, (01)00880304521155(17)180307(10)767190, (01)00880304521155(17)180330(10)766930, (01)00880304521155(17)180313(10)789110, (01)00880304521155(17)180430(10)031190, (01)00880304521155(17)180405(10)031210, (01)00880304521155(17)180405(10)031320, (01)00880304521155(17)181101(10)265710, (01)00880304521155(17)190101(10)349900, (01)008

Source

Official record: FDA (Device enforcement) ↗

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

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