BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

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

Code information: ***Lot Numbers*** 860650, 215420, 555520, 583840, 089450, 283340, 132840, 413160, 058040, 181870, 408950, 409050, 409080, 851260, 234340, 338950, 581670, 201250, 518970, 024030, 030980, 166060, 219540, 219550, 219570, 429550, 296820, 296830, 296840, 296850, 298770, 041360, 041370, 041380, 146580, 146590, 443590, 844530, 115350, 251890, 326910, 630420, 870230, 389150, 572890, 698780, 970100, 199840, 481720, 398100, 398130, 789650, 789640, 877250, 202480, 202490, 398090, 398080, 398100R, 789650R, 256430, 256450, 256440, 323790, 398090R, 398130R, 630420R, 789640R, 349500, 710600, 846440, 846420, 846490, 915380, 915370, 962800, 122840, 995670, 995680, 592030, 467400, 467410, 467420, 736490, 073190, 372270, 107950, 186460, 277550. ***UDI Numbers*** (01)00880304551107(17)141007(10)860650, (01)00880304551107(17)141112(10)215420, (01)00880304551107(17)181231(10)555520, (01)00880304551107(17)181231(10)583840, (01)00880304551107(17)190206(10)089450, (01)00880304551107(17)190221(10)283340, (01)00880304551107(17)190505(10)132840, (01)00880304551107(17)190530(10)413160, (01)00880304551107(17)190725(10)058040, (01)00880304551107(17)190805(10)181870, (01)00880304551107(17)190826(10)408950, (01)00880304551107(17)190826(10)409050, (01)00880304551107(17)190826(10)409080, (01)00880304551107(17)190930(10)851260, (01)00880304551107(17)191104(10)234340, (01)00880304551107(17)191111(10)338950, (01)00880304551107(17)191209(10)581670, (01)00880304551107(17)200318(10)201250, (01)00880304551107(17)200331(10)518970, (01)00880304551107(17)200430(10)024030, (01)00880304551107(17)200501(10)030980, (01)00880304551107(17)200515(10)166060, (01)00880304551107(17)200521(10)219540, (01)00880304551107(17)200522(10)219550, (01)00880304551107(17)200522(10)219570, (01)00880304551107(17)200611(10)429550, (01)00880304551107(17)200901(10)296820, (01)00880304551107(17)200901(10)296830, (01)00880304551107(17)200901(10)296840, (01)00880304551107(17)200901(10)296850, (01)00880304551107(17)200902(10)298770, (01)00880304551107(17)201109(10)041360, (01)00880304551107(17)201110(10)041370, (01)00880304551107(17)201109(10)041380, (01)00880304551107(17)201119(10)146580, (01)00880304551107(17)201119(10)146590, (01)00880304551107(17)201218(10)443590, (01)00880304551107(17)210126(10)844530, (01)00880304551107(17)210217(10)115350, (01)00880304551107(17)210227(10)251890, (01)00880304551107(17)210307(10)326910, (01)00880304551107(17)210330(10)630420, (01)00880304551107(17)210419(10)870230, (01)00880304551107(17)210606(10)389150, (01)00880304551107(17)210622(10)572890, (01)00880304551107(17)210701(10)698780, (01)00880304551107(17)210725(10)970100, (01)00880304551107(17)210808(10)199840, (01)00880304551107(17)210908(10)481720, (01)00880304551107(17)220523(10)398100, (01)00880304551107(17)220603(10)398130, (01)00880304551107(17)220603(10)789650, (01)00880304551107(17)220611(10)789640, (01)00880304551107(17)220608(10)877250, (01)00880304551107(17)220630(10)202480, (01)00880304551107(17)220630(10)202490, (01)00880304551107(17)220823(10)398090, (01)00880304551107(17)220825(10)398080, (01)00880304551107(17)220523(10)398100R, (01)00880304551107(17)220603(10)789650R, (01)00880304551107(17)230216(10)256430, (01)00880304551107(17)230221(10)256450, (01)00880304551107(17)230228(10)256440, (01)00880304551107(17)230228(10)323790, (01)00880304551107(17)220823(10)398090R, (01)00880304551107(17)220603(10)398130R, (01)00880304551107(17)210330(10)630420R, (01)00880304551107(17)220611(10)789640R, (01)00880304551107(17)240205(10)349500, (01)00880304551107(17)240228(10)710600, (01)00880304551107(17)240306(10)846440, (01)00880304551107(17)240309(10)846420, (01)00880304551107(17)240309(10)846490, (01)00880304551107(17)240313(10)915380, (01)00880304551107(17)240314(10)915370, (01)00880304551107(17)240317(10)962800, (01)00880304551107(17)240323(10)122840, (01)00880304551107(17)240321(10)995670, (01)00880304551107(17)240321(10)995680, (01)00880304551107(17)240628(10)592030, (01)00880304551107(17)240915(10)467400, (01)00880304551107(17)240914(10)467410, (01)00880304551107(17)240913(10)467420, (01)00880304551107(17)240926(10)736490, (01)00880304551107(17)241009(10)073190, (01)00880304551107(17)241209(10)372270, (01)00880304551107(17)250116(10)107950, (01)00880304551107(17)250123(10)186460, (01)00880304551107(17)250123(10)277550

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.