BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds (9 X 125 MM, 51 MM, Silicone, Sterile) due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters. The recalled devices were distributed worldwide and within the United States to multiple states including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, and many others. The recall involves numerous lot numbers, with the earliest being lot 411170 and extending through multiple production batches.
The source document does not specify a remedy or recommended action for consumers who have received or used affected devices from the recalled lot numbers.
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*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 473150, 147200, 668750, 668810, 235310, 235260, 565730, 565740, 565780, 565800, 565750, 230020, 096010, 096030, 095830, 688290, 688390, 688400, 976900, 977070, 977080, 239190, 239390, 310050, 310180, 310200, 757930, 978060, 107630, 219920, 260550, 436940, 572340, 572350, 718010, 910910, 996970, 139640, 215600, 447340, 518820, 712320, 270170, 411560, 525340, 619980, 789360, 983800, 207230, 356350, 600710, 658360, 804860, 115880, 274120, 411240, 512260, 610620, 719040, 039580, 735560, 735570, 160950, 628310, 627970, 628320, 628330, 711810, 711820, 765470, 284700, 284710, 488480, 488490, 488500, 051450, 051460, 051470, 051480, 051490, 051500, 162780, 607690, 607700, 722770, 723210, 038660, 038670, 428720, 647320, 647330, 774580, 428700, 994880, 229280, 229290, 740300, 740310, 935460, 935480, 241700, 241820, 409670, 409680, 521740, 521750, 417820, 417840, 417830, 513610, 235260R, 737800, 737810, 755040, 756770, 754990, 755010, 755030, 755060, 755100, 755110, 756790, 756810, 756820, 756830, 756840, 756870, 202430, 202450, 737790, 756850, 520170, 520180, 520190, 310180R, 705570, 705580, 732030, 668750R, 118140, 658600R, 378140, 378130, 378150, 378160, 378170, 520940, 765900, 765920, 765960, 766390, 766420, 766740, 766750, 765890, 766760, 520920, 765880, 765930, 765970, 043400, 043410, 043430, 043450, 043470, 765950, 310200R, 147210R, 409680R, 348050, 347610, 348010, 348020, 348
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.