BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Enforcement
- Recall Number
- Z-1646-2020
- Event ID
- 85153
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 15, 2020
- Initiation Date
- February 26, 2020
- Classification Date
- April 3, 2020
- Termination Date
- July 29, 2021
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
***Lot Numbers*** 087760, 558520, 558530, 654110, 469440, 926010, 718110, 083550, 341040, 474120, 662900, 306900, 914850, 265670, 551790, 941370, 941390, 817670, 158400, 141900, 188770, 061830, 463840, 364220, 816770, 816790, 374950, 655500, 792150, 092520, 655490, 770990, 683080, 683090, 981350, 997440, 997450, 912470, 912480, 624170, 624180, 665060, 552360, 265670R, 306900R, 232960, 233000, 233060, 547570, 547670, 552360R, 226520, 809460, 547650, 547680, 809270, 071410, 071430, 071450, 164150, 223370, 431360, 487280, 552580, 401640, 401650, 401670, 295510, 941390R, 226530, 143780, 303410, 737410, 988920, 223390, 295520, 920600, 683080R, 639430, 639490, 639540, 639550, 639510, 639530, 639560, 639590, 777450, 777570, 777600, 052660, 312640, 455040, 639440, 639480, 765330, 765340, 777390, 778120, 778130, 813840, 877540, 037550, 210740, 547570R, 709650, 777290, 777300, 788910, 807230, 807240, 856340, 029030, 029050, 807260, 330970, 813820, 465410, 488050, 554620, 554630, 554660, 605690, 657890, 758500, 807230R, 810950, 865860, 865890, 910090, 910120, 946910. ***UDI Numbers*** (01)00880304521179(17)160728(10)087760, (01)00880304521179(17)160828(10)558520, (01)00880304521179(17)160828(10)558530, (01)00880304521179(17)160928(10)654110, (01)00880304521179(17)161228(10)469440, (01)00880304521179(17)170928(10)926010, (01)00880304521179(17)171207(10)718110, (01)00880304521179(17)171228(10)083550, (01)00880304521179(17)180118(10)341040, (01)00880304521179(17)180130(10)474120, (01)00880304521179(17)180218(10)662900, (01)00880304521179(17)180503(10)306900, (01)00880304521179(17)180731(10)914850, (01)00880304521179(17)180827(10)265670, (01)00880304521179(17)180926(10)551790, (01)00880304521179(17)190218(10)941370, (01)00880304521179(17)190224(10)941390, (01)00880304521179(17)191016(10)817670, (01)00880304521179(17)190822(10)158400, (01)00880304521179(17)191103(10)141900, (01)00880304521179(17)191202(10)188770, (01)00880304521179(17)200218(10)061830, 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(01)00880304521179(17)220725(10)233000, (01)00880304521179(17)220725(10)233060, (01)00880304521179(17)220822(10)547570, (01)00880304521179(17)220822(10)547670, (01)00880304521179(17)211102(10)552360R, (01)00880304521179(17)220906(10)226520, (01)00880304521179(17)221130(10)809460, (01)00880304521179(17)221211(10)547650, (01)00880304521179(17)221207(10)547680, (01)00880304521179(17)221206(10)809270, (01)00880304521179(17)221229(10)071410, (01)00880304521179(17)230106(10)071430, (01)00880304521179(17)221227(10)071450, (01)00880304521179(17)230106(10)164150, (01)00880304521179(17)230122(10)223370, (01)00880304521179(17)230122(10)431360, (01)00880304521179(17)230122(10)487280, (01)00880304521179(17)230122(10)552580, (01)00880304521179(17)230125(10)401640, (01)00880304521179(17)230125(10)401650, (01)00880304521179(17)230125(10)401670, (01)00880304521179(17)230306(10)295510, (01)00880304521179(17)190224(10)941390R, (01)00880304521179(17)221019(10)226530, (01)00880304521179(17)230413(10)143780, (01)00880304521179(17)230414(10)303410, (01)00880304521179(17)230412(10)737410, (01)00880304521179(17)230412(10)988920, (01)00880304521179(17)221229(10)223390, (01)00880304521179(17)230125(10)295520, (01)00880304521179(17)230505(10)920600, (01)00880304521179(17)210202(10)683080R, (01)00880304521179(17)240514(10)639430, (01)00880304521179(17)240514(10)639490, (01)00880304521179(17)240514(10)639540, (01)00880304521179(17)240514(10)639550, (01)00880304521179(17)240514(10)639510, (01)00880304521179(17)240516(10)639530, (01)00880304521179(17)240514(10)639560, (01)00880304521179(17)240514(10)639590, (01)00880304521179(17)240525(10)777450, (01)00880304521179(17)240525(10)777570, (01)00880304521179(17)240607(10)777600, (01)00880304521179(17)240618(10)052660, (01)00880304521179(17)240613(10)312640, (01)00880304521179(17)240717(10)455040, (01)00880304521179(17)240729(10)639440, (01)00880304521179(17)240514(10)639480, (01)00880304521179(17)240607(10)765330, (01)00880304521179(17)240607(10)765340, (01)00880304521179(17)240618(10)777390, (01)00880304521179(17)240607(10)778120, (01)00880304521179(17)240623(10)778130, (01)00880304521179(17)240623(10)813840, (01)00880304521179(17)240618(10)877540, (01)00880304521179(17)240830(10)037550, (01)00880304521179(17)240830(10)210740, (01)00880304521179(17)220822(10)547570R, (01)00880304521179(17)240925(10)709650, (01)00880304521179(17)240924(10)777290, (01)00880304521179(17)241001(10)777300, (01)00880304521179(17)240926(10)788910, (01)00880304521179(17)241003(10)807230, (01)00880304521179(17)241003(10)807240, (01)00880304521179(17)241003(10)856340, (01)00880304521179(17)241012(10)029030, (01)00880304521179(17)241012(10)029050, (01)00880304521179(17)241011(10)807260, (01)00880304521179(17)241023(10)330970, (01)00880304521179(17)241023(10)813820, (01)00880304521179(17)241105(10)465410, (01)00880304521179(17)241105(10)488050, (01)00880304521179(17)241119(10)554620, (01)00880304521179(17)241118(10)554630, (01)00880304521179(17)241119(10)554660, (01)00880304521179(17)241119(10)605690, (01)00880304521179(17)241205(10)657890, (01)00880304521179(17)241205(10)758500, (01)00880304521179(17)241003(10)807230R, (01)00880304521179(17)241217(10)810950, (01)00880304521179(17)241217(10)865860, (01)00880304521179(17)241218(10)865890, (01)00880304521179(17)250111(10)910090, (01)00880304521179(17)250111(10)910120, (01)00880304521179(17)250111(10)946910
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.
230,001