BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

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

Code information: ***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)00880304447158(17)270825(10)732050, (01)00880304447158(17)190201(10)191510R, (01)00880304447158(17)200301(10)836740R, (01)00880304447158(17)271127(10)118030, (01)00880304447158(17)280301(10)302380, (01)00880304447158(17)280301(10)302480, (01)00880304447158(17)280315(10)378190, (01)00880304447158(17)280322(10)766220, (01)00880304447158(17)280417(10)021750, (01)00880304447158(17)280420(10)021730, (01)00880304447158(17)280430(10)921330, (01)00880304447158(17)200901(10)162260R, (01)00880304447158(17)290206(10)386330, (01)00880304447158(17)290206(10)386300, (01)00880304447158(17)290421(10)399990, (01)00880304447158(17)290421(10)417210, (01)00880304447158(17)290422(10)417220, (01)00880304447158(17)290430(10)337710, (01)00880304447158(17)271127(10)118030R, (01)00880304447158(17)270825(10)732050R 732050R.

Distribution pattern: 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.