BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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

Code information: ***Lot Numbers*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 281740, 409230, 409310, 409330, 196720, 196730, 338940, 452050, 581680, 776930, 386800, 233600, 079220, 204510, 262240, 429580, 595980, 849850, 849760, 041390, 041400, 041410, 041420, 041430, 245100, 245110, 245120, 245130, 779360, 915810, 115430, 152270, 326930, 441890, 665300, 924180, 009460, 169730, 389160, 424210, 723180, 723190, 743960, 199850, 970110, 390630, 732410, 398180, 398230, 398190, 398210, 398220, 789770, 789720, 789810, 877270, 202530, 789770R, 789810R, 202530R, 398190R, 674330, 674370, 809050, 325580, 916160, 916170, 916180, 916200, 219810, 398230R, 789720R, 349550, 349560, 349540, 710640, 710650, 846810, 713920, 847000, 847030, 847050, 847140, 846860, 847160, 399490, 399500, 417030, 417010, 417020, 073050, 455050, 704980, 799220, 838250, 918280, 532640, 532660, 028890, 585150, 525420,***UDI Numbers*** (01)00880304551091(17)141007(10)860790, (01)00880304551091(17)141112(10)215440, (01)00880304551091(17)181130(10)381650, (01)00880304551091(17)181231(10)555570, (01)00880304551091(17)190213(10)089680, (01)00880304551091(17)190225(10)283390, (01)00880304551091(17)190320(10)509720, (01)00880304551091(17)190331(10)657620, (01)00880304551091(17)190505(10)132830, (01)00880304551091(17)190528(10)372720, (01)00880304551091(17)190731(10)097250, (01)00880304551091(17)190818(10)281740, (01)00880304551091(17)190826(10)409230, (01)00880304551091(17)190826(10)409310, (01)00880304551091(17)190826(10)409330, (01)00880304551091(17)191103(10)196720, (01)00880304551091(17)191103(10)196730, (01)00880304551091(17)191111(10)338940, (01)00880304551091(17)191119(10)452050, (01)00880304551091(17)191209(10)581680, (01)00880304551091(17)191223(10)776930, (01)00880304551091(17)200314(10)386800, (01)00880304551091(17)200330(10)233600, (01)00880304551091(17)200512(10)079220, (01)00880304551091(17)200521(10)204510, (01)00880304551091(17)200522(10)262240, (01)00880304551091(17)200610(10)429580, (01)00880304551091(17)200706(10)595980, (01)00880304551091(17)200725(10)849850, (01)00880304551091(17)200727(10)849760, (01)00880304551091(17)201111(10)041390, (01)00880304551091(17)201111(10)041400, (01)00880304551091(17)201111(10)041410, (01)00880304551091(17)201110(10)041420, (01)00880304551091(17)201111(10)041430, (01)00880304551091(17)201130(10)245100, (01)00880304551091(17)201130(10)245110, (01)00880304551091(17)201130(10)245120, (01)00880304551091(17)201130(10)245130, (01)00880304551091(17)210119(10)779360, (01)00880304551091(17)210201(10)915810, (01)00880304551091(17)210217(10)115430, (01)00880304551091(17)210224(10)152270, (01)00880304551091(17)210307(10)326930, (01)00880304551091(17)210321(10)441890, (01)00880304551091(17)210407(10)665300, (01)00880304551091(17)210425(10)924180, (01)00880304551091(17)210503(10)009460, (01)00880304551091(17)210517(10)169730, (01)00880304551091(17)210603(10)389160, (01)00880304551091(17)210606(10)424210, (01)00880304551091(17)210705(10)723180, (01)00880304551091(17)210705(10)723190, (01)00880304551091(17)210711(10)743960, (01)00880304551091(17)210808(10)199850, (01)00880304551091(17)210803(10)970110, (01)00880304551091(17)210831(10)390630, (01)00880304551091(17)210929(10)732410, (01)00880304551091(17)220518(10)398180, (01)00880304551091(17)220523(10)398230, (01)00880304551091(17)220523(10)398190, (01)00880304551091(17)220603(10)398210, (01)00880304551091(17)220603(10)398220, (01)00880304551091(17)220601(10)789770, (01)00880304551091(17)220612(10)789720, (01)00880304551091(17)220611(10)789810, (01)00880304551091(17)220608(10)877270, (01)00880304551091(17)220701(10)202530, (01)00880304551091(17)220601(10)789770R, (01)00880304551091(17)220611(10)789810R, (01)00880304551091(17)220701(10)202530R, (01)00880304551091(17)220523(10)398190R, (01)00880304551091(17)221018(10)674330, (01)00880304551091(17)221018(10)674370, (01)00880304551091(17)221106(10)809050, (01)00880304551091(17)221211(10)325580, (01)00880304551091(17)230205(10)916160, (01)00880304551091(17)230204(10)916170, (01)00880304551091(17)230205(10)916180, (01)00880304551091(17)230206(10)916200, (01)00880304551091(17)230330(10)219810, (01)00880304551091(17)220523(10)398230R, (01)00880304551091(17)220612(10)789720R, (01)00880304551091(17)240203(10)349550, (01)00880304551091(17)240205(10)349560, (01)00880304551091(17)240210(10)349540, (01)00880304551091(17)240306(10)710640, (01)00880304551091(17)240228(10)710650, (01)00880304551091(17)240307(10)846810, (01)00880304551091(17)240308(10)713920, (01)00880304551091(17)240307(10)847000, (01)00880304551091(17)240307(10)847030, (01)00880304551091(17)240313(10)847050, (01)00880304551091(17)240309(10)847140, (01)00880304551091(17)240314(10)846860, (01)00880304551091(17)240326(10)847160, (01)00880304551091(17)240416(10)399490, (01)00880304551091(17)240416(10)399500, (01)00880304551091(17)240501(10)417030, (01)00880304551091(17)240502(10)417010, (01)00880304551091(17)240502(10)417020, (01)00880304551091(17)240621(10)073050, (01)00880304551091(17)240628(10)455050, (01)00880304551091(17)240802(10)704980, (01)00880304551091(17)240802(10)799220, (01)00880304551091(17)240801(10)838250, (01)00880304551091(17)240731(10)918280, (01)00880304551091(17)240912(10)532640, (01)00880304551091(17)240912(10)532660, (01)00880304551091(17)241008(10)028890, (01)00880304551091(17)241110(10)585150, (01)00880304551091(17)241109(10)525420, (01)00880304551091(17)220603(10)398210R 398210R.

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.