BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold (17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The product was distributed worldwide, including throughout most U.S. states. The recall involves numerous lot numbers and associated UDI (Unique Device Identifier) numbers spanning products from January 2019 through 2027.
The affected lot numbers include 919110, 191510, 414530, 650030, 931530, and many others documented in the recall notice. The source document 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*** 919110, 191510, 414530, 650030, 931530, 836760, 836740, 162280, 162260, 285580, 285590, 668840, 036370, 390550, 613860, 518830, 555610, 207250, 913770, 628380, 286980, 336640, 057600, 143950, 329700, 115650, 737870, 732050, 191510R, 836740R, 118030, 302380, 302480, 378190, 766220, 021750, 021730, 921330, 162260R, 386330, 386300, 399990, 417210, 417220, 337710, 118030R,***UDI Numbers*** (01)00880304447158(17)190128(10)919110, (01)00880304447158(17)190201(10)191510, (01)00880304447158(17)191028(10)414530, (01)00880304447158(17)191001(10)650030, (01)00880304447158(17)191228(10)931530, (01)00880304447158(17)200328(10)836760, (01)00880304447158(17)200301(10)836740, (01)00880304447158(17)200828(10)162280, (01)00880304447158(17)200928(10)162260, (01)00880304447158(17)210328(10)285580, (01)00880304447158(17)210428(10)285590, (01)00880304447158(17)210928(10)668840, (01)00880304447158(17)221203(10)036370, (01)00880304447158(17)230821(10)390550, (01)00880304447158(17)230919(10)613860, (01)00880304447158(17)231209(10)518830, (01)00880304447158(17)231212(10)555610, (01)00880304447158(17)240518(10)207250, (01)00880304447158(17)241014(10)913770, (01)00880304447158(17)250325(10)628380, (01)00880304447158(17)250901(10)286980, (01)00880304447158(17)250914(10)336640, (01)00880304447158(17)260210(10)057600, (01)00880304447158(17)260510(10)143950, (01)00880304447158(17)260818(10)329700, (01)00880304447158(17)270627(10)115650, (01)00880304447158(17)270627(10)737870, (01)008803044
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.