ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
Published February 26, 2014 · Recall initiated: October 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- 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.
- Lot
- 60587172 60642426 60674247 60691374 60749915 60813568 60897964 60897965 60897966 60966659 60090438 60092202 60092203 60620584 60642427 60654140 60691390 60749916 60813570 60915915 60915916 60915917 60087121 60092204 60092205 60642428 60654141 60674248 60714649 60747680 60749917 60813572 60831102 60915929 60915930 60915931 60915932 60092206 60092207 60630503 60642429 60654142 60674249 60691392 60714651 60789796 60789797 60889685 60931200 61031022 61031023 60092208 60092209 60532938 60561134 60570051 60587174 60630504 60642430 60654144 60674250 60691399 60749918 60789811 60813573 60831103 60915853 60915859 60915881 60915882 60966668 61031028 61420306 61432404 60087123 60090440 60092210 60092211 60535276 60562837 60654146 60691414 60749919 60813595 60813596 60813597 60831104 60915940 60915943 61031024 61031025 61120332 61432405 60090442 60092212 60092213 60552204 60620589 60654147 60654148 60714654 60749920 60813598 60832686 60889687 60915918 60915919 60915921 61004060 61031029 61100833 61120333 60090443 60092215 60615944 60630505 60654149 60674251 60691416 60749921 60789807 60813599 60831105 60915884 60915885 60915887 61031027 61100835 60090444 60253827 60620591 60654151 60714656 60749922 60789794 60853697 60897968 60897969 60958487 60966666 60092220 60092221 60642432 60674252 60691436 60749923 60789793 60897961 60897962 60897963 60966667 60085615 60087126 60552203 60554585 60654153 60747681 60749924 60813601 60915937 60915938 60915939 60079503 60079505 60103543 60103544 60103545 60119931 60124048 60131328 60131329 60136433 60136434 60139743 60143336 60143337 60155221 60155222 60169687 60169688 60173964 60173966 60219063 60219064 60225895 60236611 60236621 60278602 60293977 60310068 60324201 60338316 60338317 60361131 60361132 60361133 60363705 60368193 60368194 60398160 60451902 60451903 60472738 60487398 60489887 60515451 60515452 60536773 60537997 60550819 60550820 60568228 60568231 60583769 60583771 60583772 60603370 60603371 60612896 60612897 60630467 60641825 60641826 60654212 60654213 60654214 60672037 60672038 60687549 60687550 60715158 60715159 60715160 60715161 60735620 60735621 60755599 60777944 60777945 60805306 60807992 60819984 60819985 60819987 60819988 60958972 60958973 60958974 60958976 60958977 60968162 60968163 60974993 61037771 61037777 61037779 61037783 61037784 61040597 61086163 61117691 61119018 61120809 61120813 61120815 61179456 61187546 61187547 61195408 61195410 61195411 61206018 61210317 61234841 61234844 61234845 61242697 61249760 61290763 61314557 61317564 61352215 61352216 61440377 61445347 61485038 61502942 60583771R 60603370R 60612897R 60715159R 60735620R 60807992R 61120809R 61357119R 367284 367900 60088756 60093744 60095370 60095371 60095372 60098256 60098257 60103547 60103548 60103551 60103552 60112064 60124049 60131331 60136436 60136437 60139744 60139745 60139746 60148687 60154640 60155224 60155225 60165711 60165712 60169690 60173969 60173970 60187104 60187105 60208403 60208405 60208406 60208407 60219067 60219068 60219069 60219070 60225893 60225894 60231151 60231152 60236622 60236623 60247136 60252745 60252746 60260331 60260332 60260334 60260335 60266496 60270704 60270705 60274091 60274093 60278603 60293980 60293983 60303125 60303126 60303128 60303129 60324204 60324206 60324207 60324208 60338318 60338319 60338320 60338321 60338322 60348186 60348188 60361144 60361145 60361146 60361147 60361148 60361150 60361151 60363708 60363709 60368234 60368239 60368240 60398161 60407073 60411104 60411105 60425749 60451904 60451905 60451906 60451907 60451908 60454998 60472740 60472741 60472742 60479106 60489888 604898
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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