Biomet, Inc. recalls BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13

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*** 027900, 670510, 371230, 836660, 602430, 008340, 008360, 008380, 162240, 162250, 700500, 186490, 377390, 658100, 658110, 658120, 658130, 473170, 912530, 086110, 571910, 230030, 230050, 658620, 658640, 170090, 170070, 527210, 527930, 600440, 600500, 239200, 239400, 680240, 729290, 844520, 978070, 260560, 413060, 747280, 845740, 996980, 215490, 381730, 447360, 627970, 868840, 070900, 339490, 600720, 771050, 182020, 325410, 610630, 745470, 251400, 557660, 847720, 858270, 157440, 328640, 628360, 628430, 790270, 238740, 514580, 679770, 953140, 197720, 336630, 152540, 527470, 647360, 945690, 057590, 229330, 759540, 949860, 258720, 332610, 787070, 595080, 595090, 737830, 737840, 737850, 755150, 755160, 755170, 737860, 755120, 755130, 755140, 757300, 202130, 202460, 733920R, 733910R, 732040, 118130, 416640R, 141060, 141040, 378370, 378390, 765990, 766020, 766030, 766050, 766060, 043910, 921310, 766080, 234700, 234710, 473170R, 350740, 350940, 658620R, 347850, 347840, 347980, 347830, 157440R, 318670, 337700, 318660, 318680, 318690, 318860, 337580, 337650, 337660, 350360, 350370, 350390, 350540, 350560, 318850, 337460, 337500, 350380, 350550, 383600, 383610, 383630, 337470, 070900R,***UDI Numbers*** (01)00880304447172(17)190128(10)027900, (01)00880304447172(17)190628(10)670510, (01)00880304447172(17)200128(10)371230, (01)00880304447172(17)200428(10)836660, (01)00880304447172(17)200628(10)602430, (01)00880304447172(17)200828(10)008340, (01)00880304447172(17)200801(10)008360, (01)00880304447172(17)200828(10)008380, (01)00880304447172(17)200928(10)162240, (01)00880304447172(17)200928(10)162250, (01)00880304447172(17)201028(10)700500, (01)00880304447172(17)201228(10)186490, (01)00880304447172(17)201228(10)377390, (01)00880304447172(17)210228(10)658100, (01)00880304447172(17)210228(10)658110, (01)00880304447172(17)210228(10)658120, (01)00880304447172(17)210228(10)658130, (01)00880304447172(17)210428(10)473170, (01)00880304447172(17)210628(10)912530, (01)00880304447172(17)210728(10)086110, (01)00880304447172(17)210928(10)571910, (01)00880304447172(17)220928(10)230030, (01)00880304447172(17)220928(10)230050, (01)00880304447172(17)221028(10)658620, (01)00880304447172(17)221028(10)658640, (01)00880304447172(17)221218(10)170090, (01)00880304447172(17)230109(10)170070, (01)00880304447172(17)230122(10)527210, (01)00880304447172(17)230122(10)527930, (01)00880304447172(17)230125(10)600440, (01)00880304447172(17)230125(10)600500, (01)00880304447172(17)230423(10)239200, (01)00880304447172(17)230424(10)239400, (01)00880304447172(17)230612(10)680240, (01)00880304447172(17)230613(10)729290, (01)00880304447172(17)230625(10)844520, (01)00880304447172(17)230717(10)978070, (01)00880304447172(17)230808(10)260560, (01)00880304447172(17)230826(10)413060, (01)00880304447172(17)230930(10)747280, (01)00880304447172(17)231016(10)845740, (01)00880304447172(17)231030(10)996980, (01)00880304447172(17)231108(10)215490, (01)00880304447172(17)231130(10)381730, (01)00880304447172(17)231205(10)447360, (01)00880304447172(17)231221(10)627970, (01)00880304447172(17)240422(10)868840, (01)00880304447172(17)240515(10)070900, (01)00880304447172(17)240602(10)339490, (01)00880304447172(17)240614(10)600720, (01)00880304447172(17)240701(10)771050, (01)00880304447172(17)240805(10)182020, (01)00880304447172(17)240825(10)325410, (01)00880304447172(17)240911(10)610630, (01)00880304447172(17)241006(10)745470, (01)00880304447172(17)241111(10)251400, (01)00880304447172(17)241208(10)557660, (01)00880304447172(17)250112(10)847720, (01)00880304447172(17)250112(10)858270, (01)00880304447172(17)250209(10)157440, (01)00880304447172(17)250224(10)328640, (01)00880304447172(17)250318(10)628360, (01)00880304447172(17)250325(10)628430, (01)00880304447172(17)250406(10)790270, (01)00880304447172(17)250527(10)238740, (01)00880304447172(17)250625(10)514580, (01)00880304447172(17)250708(10)679770, (01)00880304447172(17)250806(10)953140, (01)00880304447172(17)250904(10)197720, (01)00880304447172(17)250915(10)336630, (01)00880304447172(17)251207(10)152540, (01)00880304447172(17)251223(10)527470, (01)00880304447172(17)260113(10)647360, (01)00880304447172(17)260204(10)945690, (01)00880304447172(17)260211(10)057590, (01)00880304447172(17)260301(10)229330, (01)00880304447172(17)260411(10)759540, (01)00880304447172(17)260426(10)949860, (01)00880304447172(17)260523(10)258720, (01)00880304447172(17)260526(10)332610, (01)00880304447172(17)260711(10)787070, (01)00880304447172(17)260919(10)595080, (01)00880304447172(17)260916(10)595090, (01)00880304447172(17)270619(10)737830, (01)00880304447172(17)270618(10)737840, (01)00880304447172(17)270618(10)737850, (01)00880304447172(17)270619(10)755150, (01)00880304447172(17)270617(10)755160, (01)00880304447172(17)270617(10)755170, (01)00880304447172(17)270616(10)737860, (01)00880304447172(17)270625(10)755120, (01)00880304447172(17)270626(10)755130, (01)00880304447172(17)270624(10)755140, (01)00880304447172(17)270626(10)757300, (01)00880304447172(17)270630(10)202130, (01)00880304447172(17)270629(10)202460, (01)00880304447172(17)220101(10)733920R, (01)00880304447172(17)220101(10)733910R, (01)00880304447172(17)270825(10)732040, (01)00880304447172(17)271127(10)118130, (01)00880304447172(17)220401(10)416640R, (01)00880304447172(17)280223(10)141060, (01)00880304447172(17)280301(10)141040, (01)00880304447172(17)280228(10)378370, (01)00880304447172(17)280228(10)378390, (01)00880304447172(17)280322(10)765990, (01)00880304447172(17)280322(10)766020, (01)00880304447172(17)280323(10)766030, (01)00880304447172(17)280322(10)766050, (01)00880304447172(17)280328(10)766060, (01)00880304447172(17)280417(10)043910, (01)00880304447172(17)280417(10)921310, (01)00880304447172(17)280420(10)766080, (01)00880304447172(17)280508(10)234700, (01)00880304447172(17)280508(10)234710, (01)00880304447172(17)210401(10)473170R, (01)00880304447172(17)280516(10)350740, (01)00880304447172(17)280516(10)350940, (01)00880304447172(17)221001(10)658620R, (01)00880304447172(17)290205(10)347850, (01)00880304447172(17)290206(10)347840, (01)00880304447172(17)290207(10)347980, (01)00880304447172(17)290222(10)347830, (01)00880304447172(17)250209(10)157440R, (01)00880304447172(17)290403(10)318670, (01)00880304447172(17)290403(10)337700, (01)00880304447172(17)290405(10)318660, (01)00880304447172(17)290405(10)318680, (01)00880304447172(17)290404(10)318690, (01)00880304447172(17)290408(10)318860, (01)00880304447172(17)290404(10)337580, (01)00880304447172(17)290404(10)337650, (01)00880304447172(17)290404(10)337660, (01)00880304447172(17)290408(10)350360, (01)00880304447172(17)290409(10)350370, (01)00880304447172(17)290409(10)350390, (01)00880304447172(17)290409(10)350540, (01)00880304447172(17)290409(10)350560, (01)00880304447172(17)290409(10)318850, (01)00880304447172(17)290412(10)337460, (01)00880304447172(17)290412(10)337500, (01)00880304447172(17)290409(10)350380, (01)00880304447172(17)290410(10)350550, (01)00880304447172(17)290422(10)383600, (01)00880304447172(17)290421(10)383610, (01)00880304447172(17)290430(10)383630, (01)00880304447172(17)290506(10)337470, (01)00880304447172(17)240516(10)070900R, (01)00880304447172(17)260204(10)945690R 945690R.