BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold (15 X 155 MM, Silicone, Sterile, Item 431193) worldwide, including distribution to all U.S. states. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters during manufacturing. The affected products are identified by specific lot numbers and corresponding UDI numbers, with the earliest lot dating to July 2016 and subsequent lots continuing through later dates.
The recall document does not specify a remedy or instructions for affected consumers regarding what steps they should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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*** 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)00880
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.