BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Select Hip Stem Cement Spacer Mold (13 X 200 MM, Silicone, Sterile, Item 431197) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The recalled product was distributed worldwide and to numerous U.S. states including California, Florida, Texas, New York, and many others. The recall affects multiple lot numbers and includes specific UDI (Unique Device Identifier) numbers associated with various manufacturing dates.
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*** 331870, 050670, 628200, 977700, 487840, 680310, 062930, 437310, 736420, 129860, 084270, 262430, 474140, 176350, 520540, 957200, 265730, 713220, 584750, 817700, 021270, 301460, 063240, 188820, 188830, 061870, 061860, 932970, 374990, 375000, 602360, 680450, 792230, 655550, 092840, 205930, 771040, 774460, 774450, 016170, 997520, 188490, 400250, 147560, 291850, 548320, 396960, 396950, 632020, 234510, 809670, 809680, 164180, 070740, 916120, 070650, 070710, 070720, 164170, 224520, 224530, 295880, 295890, 295900, 388410, 388430, 388440, 401930, 552620, 552630, 552640, 552650, 617990, 070690, 224510, 315420, 401920, 431570, 618010, 070730, 388420, 388460, 548610, 034780, 275370, 737120, 808040, 875330, 144810, 042920, 070730R, 639790, 639860, 639880, 639930, 262130, 639850, 639920, 639940, 639950, 313660, 313670, 326880, 374130, 717760, 717770, 717780, 717790, 717800, 717810, 717820, 717830, 717840, 812850, 813890, 813910, 809680R, 037600, 063860, 063870, 210830, 388460R, 772750, 806560, 806640, 806790, 029310, 807400, 807540, 894170, 117910, 250580, 331000, 488060, 554700, 605700, 673830, 689840, 689850, 834890, 813910R, 834900, 834920, 834880, 834910, 865950, 865940, 946990,***UDI Numbers*** (01)00880304521148(17)160128(10)331870, (01)00880304521148(17)160628(10)050670, (01)00880304521148(17)160928(10)628200, (01)00880304521148(17)161128(10)977700, (01)00880304521148(17)170428(10)487840, (01)00880304521148(17)170528(10)680310, (01)00880304521148(17)170628(10)06293
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.