FDAFDA · Alimentos y medicamentos·N.º oficial Z-1024-2014
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY ACET SHELL 56MM O TRILOGY ACET SHELL 58MM O TRILOGY ACET SHELL 60MM O TRILOGY ACET SHELL 62MM O TRILOGY ACET SHELL 64MM O TRILOGY ACET SHELL 66MM O TRILOGY ACET SHELL 68MM O TRILOGY ACET SHELL 70MM O TRILOGY ACET SHELL 72MM O TRILOGY ACET SHELL 74MM O TRILOGY ACET SHELL 76MM O TRILOGY ACET SHELL 78MM O TRILOGY ACET SHELL 80MM O BONE SCREW 4.5X15 SELF-TA BONE SCREW 4.5X20 SELF-TA BONE SCREW 4.5X25 SELF-TA BONE SCREW 4.5X30 SELF-TA BONE SCREW 4.5X35 SELF-TA BONE SCREW 4.5X40 SELF-TA BONE SCREW 4.5X50 SELF-TA BONE SCREW 4.5X60 SELF-TA BONE SCREW 6.5X15 SELF-TA BONE SCREW 6.5X20 SELF-TA BONE SCREW 6.5X25 SELF-TA BONE SCREW 6.5X30 SELF-TA BONE SCREW 6.5X35 SELF-TA BONE SCREW 6.5X40 SELF-TA BONE SCREW 6.5X50 SELF-TA BONE SCREW 6.5X60 SELF-TA BONE SCREW 6.5X70 SELF-TA BONE SCREW 6.5X80 SELF-TA
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
- 366971 60384272 60838522 61558081 60159292 60690384 60926262 61215883 61559843 61567731 61611793 60069675 60160804 60225912 60427290 60690394 60813602 60926263 61050686 61095381 61292658 61459870 61564135 61783434 61930401 62268587 60069675R 61157229 60042677 62243630 367119 60077122 60254935 60331076 60402575 60479496 60601302 60690396 60824152 60877128 61128097 61201897 61263144 61471012 61580824 61906180 61921675 60481374 369642 60675755 366453 367366 367898 369730 370449 60068486 60121239 60126675 60126676 60146168 60181426 60200570 60202526 60216477 60225913 60237051 60294477 60365231 60368737 60431168 60479084 60482633 60550826 60550828 60568252 60586275 60601305 60601306 60653796 60653797 60661219 60690399 60704848 60704849 60724503 60750887 60750888 60813603 60813604 60824170 60838528 60845664 60890073 60926264 60926265 60950165 60954659 60955591 60982888 60998689 61008548 61050687 61050689 61076195 61080146 61080147 61126792 61142157 61150949 61150950 61168263 61199815 61201845 61263145 61263146 61281167 61283615 61292660 61309774 61321048 61329084 61374925 61403503 61412019 61412020 61452210 61470969 61471011 61486653 61486654 61528582 61533558 61533559 61580825 61580826 61580827 61638696 61638698 61734419 61758219 61783436 61809006 61817461 61825846 61837767 61906445 61911378 61930403 61945055 61957085 62052788 62055820 62099618 62102507 62158151 62183129 62189393 62281814 62291870 60358224 60513008 60890113 61176450 60513008R 367528 369648 60897498 60950229 365711 366188 370606 60068487 60082444 60099809 60109102 60109103 60109104 60109106 60121241 60121243 60121244 60126802 60126803 60126804 60126807 60146170 60146171 60146172 60160807 60181430 60188266 60188267 60202529 60237055 60237056 60254946 60254948 60287158 60287160 60287165 60294481 60331083 60331086 60348931 60365236 60365239 60382059 60382060 60427293 60427294 60429610 60431172 60446282 60479532 60479533 60479534 60479535 60528763 60550835 60601312 60653805 60653807 60690415 60704852 60704853 60708778 60708780 60724508 60750889 60750893 60750895 60804638 60804640 60813606 60813607 60813609 60813625 60830902 60830905 60838529 60845665 60858928 60877130 60877131 60890074 60926269 60954660 60955593 61021272 61038466 61076196 61076199 61080148 61080152 61080166 61088758 61093617 61112392 61126794 61142159 61150954 61176411 61201851 61215901 61216901 61269930 61283617 61292661 61360114 61374927 61374928 61397892 61397895 61412022 61425778 61454829 61454831 61455777 61533562 61564136 61580833 61635717 61640786 61640789 61640790 61732765 61734247 61779020 61783438 61803761 61808988 61820780 61825847 61825848 61846473 61873601 61906446 61911379 61920504 61939314 61945056 61999739 62022695 62036845 62055823 62055824 62099619 62113206 62113208 62141785 62141786 62172018 62228364 62234431 62235711 62240231 62240232 62278668 62285245 62291871 62307740 60358223 60360854 60480720 60804678 60926255 61162481 61454835 368945 370032 60481394 60545352 60909888 62243614 60077126 60163344 365709 366187 366460 366640 366937 367154 60109108 60109109 60121247 60126879 60126880 60126881 60126883 60126885 60146177 60146179 60146180 60160848 60160849 60163348 60163349 60163350 60181431 60181433 60181434 60188272 60188273 60188274 60202534 60225924 60237084 60254952 60254954 60254955 60254956 60287118 60294485 60294487 60294489 60331091 60331093 60331094 60365242 60382061 60382062 60382064 60402584 60411425 60411427 60427296 60431176 60479540 60487894 60511017 60513276 60550840 60553761 60586279 60601333 60601336 60601337 60623496 60640196 60653818 60653819 60672924 60690436 60708794
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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