FDAFDA · Alimentos y medicamentos·N.º oficial Z-1478-2020
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.
Publicado el 25 de marzo de 2020 · Inicio del retiro: 21 de enero de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Aesculap Implant Systems LLC
- Distribuidor
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.
- Lote
- All product with old packaging configuration. New packaging configuration begins with Lot 52533610. Lots recalled: 51304393 51305032 51308465 51308467 51308475 51308477 51309717 51309718 51309719 51309720 51309721 51309722 51309724 51309725 51309726 51309727 51309728 51309751 51309752 51309753 51309757 51309771 51309772 51311075 51311078 51311083 51312411 51312419 51312426 51312436 51313562 51313563 51313564 51313565 51313566 51313569 51313570 51313797 51314080 51314081 51316258 51316259 51316260 51316281 51316282 51316283 51316288 51316292 51316302 51317871 51317872 51317879 51317882 51317883 51319365 51319376 51319377 51320769 51322218 51322219 51322220 51322241 51322242 51322680 51322708 51323350 51323353 51323354 51323355 51323401 51323402 51324438 51324732 51324733 51324734 51324735 51324736 51324737 51324804 51324805 51324816 51324818 51324820 51324821 51324822 51325086 51325087 51325088 51325089 51325090 51325091 51325092 51325289 51325290 51325291 51325372 51325377 51325378 51325941 51325942 51325944 51325945 51326016 51326441 51326442 51326789 51326790 51326791 51327272 51327273 51327637 51327638 51327639 51327640 51328695 51328696 51328697 51328698 51328777 51329293 51330087 51330141 51330142 51330143 51330144 51330895 51331651 51331652 51331653 51331654 51331877 51331891 51332152 51332153 51332155 51333609 51333610 51333691 51334995 51334996 51334998 51334999 51335000 51335001 51335002 51335485 51335834 51335835 51335942 51336332 51336548 51336552 51336553 51336823 51336824 51336825 51337400 51337690 51337691 51337912 51337914 51338161 51338493 51338494 51338495 51338496 51338498 51338528 51339366 51339619 51340021 51341027 51341028 51341029 51341030 51341033 51341034 51341264 51341265 51341650 51341651 51342012 51342013 51342014 51342672 51342673 51342818 51342819 51342820 51342821 51342823 51343067 51343247 51343248 51343623 51343624 51344141 51344142 51344143 51344144 51344298 51344300 51344676 51345078 51345376 51345377 51346224 51346225 51346227 51346228 51346229 51346396 51346397 51346398 51347305 51347320 51347321 51347322 51348085 51348171 51348967 51348968 51348970 51348971 51348972 51349542 51349543 51349544 51349550 51349551 51349552 51349553 51349556 51349557 51349890 51349891 51349893 51349894 51349895 51349896 51349897 51350496 51350497 51350498 51350499 51350500 51350721 51350722 51350723 51350724 51350790 51350791 51351027 51351028 51351029 51351031 51351635 51351636 51351880 51352051 51352052 51352565 51353053 51353054 51353055 51353845 51353846 51354646 51354647 51354660 51354702 51354703 51354704 51354773 51355298 51355429 51356060 51356063 51356065 51356382 51356383 51356384 51356822 51358122 51358714 51358715 51358716 51358946 51358947 51359135 51359608 51359850 51359851 51359852 51360749 51360820 51361349 51361350 51361352 51361353 51362368 51362369 51362370 51362371 51363880 51364444 51364455 51364456 51364599 51365294 51365295 51365296 51365298 51365611 51365794 51365852 51365854 51366116 51366577 51367169 51367170 51367171 51367690 51368227 51368228 51368229 51368230 51368681 51368682 51368997 51368998 51369126 51369127 51369802 51369803 51369804 51369805 51370542 51370543 51370546 51370547 51370843 51371122 51371123 51372128 51372129 51372130 51372654 51372859 51372949 51372950 51372951 51372953 51372954 51372955 51373474 51373475 51373836 51373837 51373839 51373840 51373841 51373842 51373843 51374131 51374762 51374773 51374774 51374775 51374776 51374777 51374778 51374779 51374892 51374893 51374894 51375024 51375996 51376138 51376141 51376322 51376729 51376826 51376827 51376833 51376834 51376836 51377562
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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