Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1647-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 26, 2020

Date Posted: April 15, 2020

Recall Number: Z-1647-2020

Event ID: 85153

Reason for Recall:

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

Status: Terminated

Product Quantity: 230,001

Code Information:

***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)00880304521155(17)190731(10)654570, (01)00880304521155(17)190807(10)927670, (01)00880304521155(17)190814(10)767300, (01)00880304521155(17)190813(10)817690, (01)00880304521155(17)191202(10)188780, (01)00880304521155(17)191204(10)188790, (01)00880304521155(17)200511(10)932920, (01)00880304521155(17)200609(10)205930, (01)00880304521155(17)200722(10)429810, (01)00880304521155(17)200805(10)655510, (01)00880304521155(17)201019(10)092640, (01)00880304521155(17)201109(10)757250, (01)00880304521155(17)201208(10)771000, (01)00880304521155(17)210215(10)683180, (01)00880304521155(17)210222(10)803570, (01)00880304521155(17)210321(10)217230, (01)00880304521155(17)210330(10)197360, (01)00880304521155(17)210616(10)291810, (01)00880304521155(17)210831(10)799130, (01)00880304521155(17)211105(10)552560, (01)00880304521155(17)220629(10)974130, (01)00880304521155(17)220518(10)249280, (01)00880304521155(17)220524(10)249290, (01)00880304521155(17)220726(10)233870, (01)00880304521155(17)191204(10)188790R, (01)00880304521155(17)221211(10)547700, (01)00880304521155(17)221219(10)116180, (01)00880304521155(17)221229(10)071090, (01)00880304521155(17)230109(10)071100, (01)00880304521155(17)221229(10)116160, (01)00880304521155(17)221227(10)784730, (01)00880304521155(17)230115(10)946240, (01)00880304521155(17)180307(10)767190R, (01)00880304521155(17)230320(10)487340, (01)00880304521155(17)230321(10)552590, (01)00880304521155(17)200805(10)655510R, (01)00880304521155(17)230321(10)431450, (01)00880304521155(17)230328(10)617650, (01)00880304521155(17)230416(10)617770, (01)00880304521155(17)230415(10)736810, (01)00880304521155(17)230412(10)988930, (01)00880304521155(17)230507(10)934780, (01)00880304521155(17)230511(10)920630, (01)00880304521155(17)201019(10)092640R, (01)00880304521155(17)211105(10)552560R, (01)00880304521155(17)210831(10)799130R, (01)00880304521155(17)230511(10)920630R, (01)00880304521155(17)220726(10)233870R, (01)00880304521155(17)210616(10)291810R

Distribution Pattern:

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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated