M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
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
- 367948 60314382 60630218 60691787 61053255 61064495 61117719 61303810 61367343 61434774 368764 369138 60219125 60391605 60468238 60645301 61040164 61040166 61092425 61271218 61298490 61332788 61415337 61565527 61711271 61748698 61565527R 368397 60136443 60269633 60393450 60894576 61031591 61079877 61191197 61242951 61294517 61490690 61578055 367232 367951 369139 60518287 60747414 61026918 61092426 61191198 61244794 61275552 61332789 61413348 61490691 00367232R 367735 367952 60205391 60439856 60917345 61049665 61117720 61191199 61260863 61328159 61394802 61428545 367953 368447 369593 60797052 60917346 61069777 61172854 61290214 61382432 61413349 367725 367954 369141 60820229 60969982 60970713 61290216 61382436 00367725R 367955 60222667 60231603 60977563 61191201 61382437 61445338 60231603R 367956 60205392 60969976 60999538 61275553 61344244 61512881 367933 369142 60165691 60269651 60583693 60622432 60973767 61092427 61266204 61298505 61446672 61453160 61631388 61667272 61747816 61747817 367957 60175558 60278617 60426189 60487390 60622433 60630460 60931489 61031586 61069779 61092428 61226794 61242943 61275555 61285979 61415338 61468148 61711274 367361 60154629 60175559 60684985 60973773 61069780 61113627 61155638 61290219 61458957 61632569 60175559R 60973773R 367934 368448 60139737 60208383 60377209 60426190 60472556 60922833 61069782 61113628 61191202 61413350 61584830 367928 369144 60913694 61159195 61313806 61328160 61415339 60913694R 61159195R 61328160R 367935 368449 369145 61053248 61097069 61191203 61415340 367959 368450 60205393 61231968 61233990 61341152 61395129 61584831 60205393R 61395129R 367960 369146 60685553 60735612 60999519 61117721 61338942 367726 367936 368192 60104823 60119139 60136445 60173954 60216381 60260479 60266612 60454980 60468259 60645310 60897830 60897855 61040167 61117722 61172853 61191230 61223093 61313802 61458958 61597136 61667273 61700135 61747820 61747821 367923 60098284 60136446 60150750 60173955 60208385 60241721 60258736 60310279 60415176 60437847 60454981 60463316 60468260 60630461 60691804 60758132 60894670 60894681 61031558 61031560 61092429 61113629 61117723 61155639 61172838 61234862 61260885 61285977 61313804 61434775 61453175 61538812 61578056 61641827 61723066 60630461R 60894671R 367961 60104825 60136447 60208387 60231264 60294034 60407616 60415177 60487391 60601779 60758133 60999573 61026915 61069788 61155640 61172834 61191231 61237554 61260860 61290222 61313803 61434776 61453166 61542204 61769268 60645318R 367937 60108198 60108199 60249228 60487393 60969979 60969980 61092430 61117724 61223094 61234857 61307943 61490694 61602077 61700153 61752962 367962 368453 61049667 61092431 61120869 61298507 61420488 61608478 61049667R 367963 60205394 61040173 61159197 61313805 61338943 61523850 61313805R 367964 369151 60973768 61290225 61382438 61523852 60187109 60388939 60468261 60684986 60897036 61064496 61281287 61490695 60468261R 367939 369152 60119140 60150751 60173957 60173958 60208389 60294037 60426192 60459737 60460805 60583694 60645302 60711442 60715136 60897037 60897038 60897039 61064497 61113630 61143371 61155641 61237555 61244806 61266200 61275557 61338944 61428546 61458972 61608479 61728582 61747825 367340 367924 60098285 60098286 60136448 60136449 60154630 60173959 60175560 60219126 60231269 60241726 60247151 60258737 60338227 60404724 60426193 60426194 60451672 60451673 60459738 60463301 60583695 60645312 60715137 60758134 60894693 60894695 60969974 60969975 60999544 61026908 61113631 61120872 61155642 61172835 61199925 61232480 61242950 61275558 61303811 61434777 61453171 6154220
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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