Biomet, Inc.: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

Is my product affected?

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

• UPC 00880304521247

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Select Hip Stem Cement Spacer Mold (13 X 145 MM, silicone, sterile, Item 431192) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The product was distributed worldwide and to numerous U.S. states including California, Florida, Texas, New York, and many others. The recall affects specific lot numbers ranging from 062130 to 5184.

The record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 135090, 341030, 262420, 789510, 843130, 843140, 020980, 063530, 258130, 306890, 554960, 916060, 143900, 369930, 713250, 068170, 135800, 387420, 266430, 817720, 424890, 271580, 467100, 158310, 158320, 158330, 063490, 188750, 188760, 388720, 847530, 061820, 354330, 354340, 816470, 816710, 374910, 374920, 374940, 670140, 655470, 792140, 655460, 722930, 792130, 092510, 205800, 364730, 655480, 759150, 771240, 799960, 770950, 770970, 064050, 981350, 691930, 683120, 683170, 683150, 803380, 691880, 912490, 912500, 624150, 624160, 444030, 564610, 563840, 996120, 777720, 777730, 866050, 866070, 444030R, 655460R, 205800R, 116150, 232830, 946080, 232790, 232820, 438450, 453800, 453820, 453840, 477550, 477580, 477590, 547510, 438360, 438420, 453810, 453850, 477570, 477600, 547520, 784740, 438280, 438320, 438380, 547470, 561190, 547490, 453750, 946070, 164130, 453780, 164140, 431330, 683120R, 034680, 950380, 988870, 618540, 875430, 988910, 275310, 303400, 736780, 143600, 438220, 438430, 934880, 935040, 042490, 453750R, 770970R, 518530, 478470, 478480, 478500, 518520, 518540, 261860, 518500, 639250, 639280, 639310, 639350, 639370, 639380, 639240, 639270, 639340, 662040, 662060, 518510, 778040, 518490, 662080, 261870, 403980, 662050, 717850, 742340, 777310, 777330, 777340, 777380, 778100, 812880, 812890, 813510, 813530, 845400, 845420, 845440, 845450, 845470, 845480, 877510, 877530, 5184

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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