BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of the BIOMET StageOne Select Hip Stem Cement Spacer Mold (9 X 200 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected product was distributed worldwide and to most U.S. states. The recall involves numerous lot numbers spanning from mid-2016 through 2017, which can be identified through specific lot numbers or UDI (Unique Device Identifier) numbers listed in the recall notice.
The recall notice does not specify a remedy or recommended action for affected consumers.
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*** 978870, 104900, 469480, 804270, 254080, 573990, 574110, 437220, 794520, 084260, 474130, 321640, 697120, 767230, 843180, 021340, 953860, 348180, 916270, 167360, 197180, 551810, 584740, 817740, 160680, 740340, 188800, 463930, 061840, 354870, 817100, 077680, 077700, 415570, 792220, 792200, 205880, 792210, 097970, 771010, 039320, 771170, 332950, 774510, 774430, 008820, 057700, 291820, 291930, 799140, 130820, 777420, 777450, 099660, 070950, 116190, 224060, 224170, 388090, 295570, 295590, 388150, 388180, 388250, 388280, 205880R, 099650, 736980, 737020, 712120, 736920, 988950, 548310, 034740, 275320, 303420, 359610, 946250, 988940, 740340R, 920850, 934760, 717470, 717510, 717530, 717540, 717550, 717560, 717570, 717590, 717440, 717480, 717490, 717520, 777640, 778140, 813850, 813870, 845500, 845510, 845520, 845530, 845540, 717460, 037570, 771010R, 084010, 037580, 152370, 717450, 326070, 717580, 580070, 772740, 788920, 788930, 777610, 789000, 807290, 807430, 807440, 807450, 029270, 055400, 580060, 807270, 807280, 807300, 807420, 883830, 807410, 792210R, 503860, 641730, 554670, 673760, 673770, 673780. ***UDI Numbers*** (01)00880304521124(17)160628(10)978870, (01)00880304521124(17)160728(10)104900, (01)00880304521124(17)161228(10)469480, (01)00880304521124(17)170228(10)804270, (01)00880304521124(17)170828(10)254080, (01)00880304521124(17)170828(10)573990, (01)00880304521124(17)170828(10)574110, (01)00880304521124(17)171028(10)437220, (01)00880304521124(17)171206(10)7945
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.