Biomet, Inc. recalls BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, S
Recalled Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Hazard / Issue
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Issued by
FDA
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, 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.
Lot/Code Info: ***Lot Numbers*** 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210,***UDI Numbers*** (01)00880304521063(17)151228(10)004800, (01)00880304521063(17)160728(10)104440, (01)00880304521063(17)170228(10)734050, (01)00880304521063(17)170728(10)082110, (01)00880304521063(17)170928(10)912150, (01)00880304521063(17)171207(10)961960, (01)00880304521063(17)180106(10)092470, (01)00880304521063(17)180219(10)630170, (01)00880304521063(17)180620(10)602290, (01)00880304521063(17)180904(10)357210, (01)00880304521063(17)190113(10)508930, (01)00880304521063(17)190505(10)474100, (01)00880304521063(17)191025(10)913740, (01)00880304521063(17)191215(10)364330, (01)00880304521063(17)200416(10)396650, (01)00880304521063(17)200706(10)295210, (01)00880304521063(17)200825(10)854280, (01)00880304521063(17)200825(10)952930, (01)00880304521063(17)201119(10)816110, (01)00880304521063(17)210126(10)362340, (01)00880304521063(17)210317(10)184510, (01)00880304521063(17)210919(10)988980, (01)00880304521063(17)220115(10)988960, (01)00880304521063(17)220620(10)827160, (01)00880304521063(17)210126(10)362340R, (01)00880304521063(17)220727(10)231990, (01)00880304521063(17)220726(10)232110, (01)00880304521063(17)221229(10)757770, (01)00880304521063(17)230116(10)757640, (01)00880304521063(17)230115(10)827170, (01)00880304521063(17)230123(10)757740, (01)00880304521063(17)230216(10)757700, (01)00880304521063(17)230417(10)118590, (01)00880304521063(17)230424(10)118580, (01)00880304521063(17)230424(10)884570, (01)00880304521063(17)191025(10)913740R, (01)00880304521063(17)240513(10)455920, (01)00880304521063(17)240528(10)569510, (01)00880304521063(17)200416(10)396650R, (01)00880304521063(17)240829(10)740650, (01)00880304521063(17)240829(10)800090, (01)00880304521063(17)240829(10)911390, (01)00880304521063(17)240828(10)926010, (01)00880304521063(17)230424(10)118580R, (01)00880304521063(17)240915(10)911440, (01)00880304521063(17)240913(10)911480, (01)00880304521063(17)240915(10)925990, (01)00880304521063(17)240913(10)926000, (01)00880304521063(17)240915(10)926040, (01)00880304521063(17)240925(10)868260, (01)00880304521063(17)240927(10)911470, (01)00880304521063(17)240926(10)926050, (01)00880304521063(17)241010(10)464210, (01)00880304521063(17)241001(10)926030 926030.
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