Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
Publicado el 26 de febrero de 2014 · Inicio del retiro: 11 de octubre de 2013
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
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
- Lote
- 369276 369524 60291473 60310301 60342024 60357090 60399558 60425903 60452829 60558758 60570479 60584084 60590812 60599272 60611906 60620113 60657785 60682169 60687824 60708283 60711104 60821371 60841560 60907093 60984963 61022804 61070950 61077603 61134756 61154119 61175581 61209547 61228859 61270001 61287201 61368475 61368477 61530412 61533227 61533467 61692052 61732327 61774928 61783774 61824402 61870194 61873807 61879216 61910402 61977973 62063907 62075334 62106829 62146121 62150826 62240863 62291985 60563149 60566878 60600179 60630361 60815719 60828775 61066145 61144414 61162703 61213636 61261189 61313751 61408337 61461416 61504803 61522363 61756178 61783396 61847265 61923132 61998438 62133204 62298309 369341 370194 60222129 60353227 60368431 60373709 60399559 60466343 60507563 60554703 60579220 60584085 60599273 60623449 60656522 60661145 60662839 60687825 60708286 60709627 60709632 60711101 60841591 60867231 60884747 60976986 60976987 61008062 61036699 61070953 61115030 61135548 61135550 61175582 61200729 61200730 61260738 61279518 61283870 61283871 61345873 61382663 61401473 61453030 61504719 61549273 61549274 61549275 61549276 61677022 61692027 61722491 61742558 61779295 61810839 61824403 61859392 61882807 61887464 61895659 61977974 61993270 62002515 62118749 62148588 62183205 62262698 62291986 60581741 60581742 60612133 60643129 60670842 60885034 61006076 61017248 61135870 61151284 61151285 61162712 61191580 61191582 61213637 61296090 61313753 61388431 61408356 61461420 61554436 61695657 61728055 61751742 61803721 61847257 61899761 61985050 62046280 62103973 62182475 62275050 62311689 369521 370193 370858 370945 60222133 60266021 60291474 60310305 60325143 60325144 60333414 60342026 60353228 60357681 60361328 60368433 60383211 60392168 60392169 60421527 60439918 60439919 60452834 60452835 60472566 60499470 60507564 60515205 60537020 60557545 60563123 60575106 60581719 60584086 60595310 60599274 60611914 60630347 60630619 60643072 60643073 60656529 60661146 60666934 60674054 60687826 60702902 60704516 60708288 60761049 60761050 60778162 60788342 60802051 60807907 60815683 60815684 60815685 60815686 60815688 60838441 60847607 60862248 60867234 60867235 60877580 60884750 60907095 60926685 60945942 60970688 60970689 60970690 60970691 61006226 61006227 61006234 61006235 61006236 61052314 61066114 61066115 61066116 61070954 61081445 61081449 61115068 61115069 61115070 61135554 61135555 61135556 61135557 61161634 61161635 61175585 61175586 61175587 61175588 61175589 61208545 61208553 61208557 61228861 61242738 61242739 61242740 61270003 61270004 61292656 61303971 61321909 61333808 61345874 61361607 61363350 61366868 61375005 61382666 61382667 61399358 61411930 61427145 61442434 61442436 61453079 61453080 61467465 61486352 61486353 61513114 61513116 61570263 61570264 61570266 61570267 61570268 61605272 61605296 61605297 61605298 61605299 61605301 61629339 61651244 61666034 61676996 61686646 61687561 61687565 61687567 61726167 61734191 61738760 61750704 61750706 61760436 61762021 61770214 61776750 61779304 61783776 61786879 61805392 61805393 61812076 61817904 61817905 61831361 61831362 61847227 61851996 61855296 61863206 61880798 61892522 61893817 61898116 61902150 61908927 61913837 61918152 61920651 61923955 61928928 61932515 61935516 61962922 61964016 61987248 61989374 61996829 61998897 61999827 62015975 62024653 62035427 62043516 62046445 62046446 62057489 62057492 62060719 62067595 62080059 62093427 62093428 62105215 62105217 62114977 62119028 62133333 62138609 62140362 62167399 62178655 62181489 62181491 62193446 62210498 622121
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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