6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
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
- 60248716 61500239 60124919 60193878 60227863 60305825 60451065 60796836 61144521 60227864 61144525 61887185 62054654 366155 60227791 60300577 60607124 60671459 60774007 60758129 60807553 60973105 60807553R 60227802 60892289 61462907 61586239 60900891 366160 369922 60114470 60153496 60177429 60197992 60227792 60265896 60308809 60382234 60499745 60552245 60737193 60929071 61052827 61203376 61713707 61864130 61866007 60265896R 369929 370590 60107297 60125487 60192043 60266060 60541831 60724231 60743135 61099150 61589279 61666186 61743037 62005415 369930 60114471 60130005 60134697 60134698 60150444 60162851 60173086 60173087 60192044 60197993 60215876 60225025 60246461 60247733 60266062 60294572 60308811 60323678 60362748 60423131 60476815 60535978 60623842 60671476 60728078 60774008 60929072 61002145 61099151 61160409 61203377 61304707 61401714 61587536 61652334 61670828 61732726 61751518 61837152 61911472 62005416 60114471R 369923 60153497 60197994 60308812 60541835 60608604 60747329 60940009 61780614 62005414 60153497R 366158 369931 60107298 60114472 60125488 60147971 60169666 60191454 60222124 60240111 60247734 60282817 60362750 60423132 60499746 60605096 60671478 60732860 60810352 60940010 61052828 61160410 61401715 61645997 61666187 61732727 61751519 61887182 60114473 60128960 60184947 60222125 60265894 60294574 60340822 60403879 60440338 60529671 60566374 60597607 60623844 60699106 60728079 60774009 60800969 60847639 60929073 60929075 61052829 61052830 61099152 61160411 61179796 61224840 61281512 61462909 61530673 61543470 61589278 61603830 61618474 61713704 61732725 61758468 61801238 61808407 61833352 61864131 61866008 61906271 61957512 61977935 62038434 62094968 60099535 60124920 60192050 60233947 60265898 60294573 60323679 60359305 60392803 60440339 60476817 60529670 60541839 60586138 60623849 60699107 60740543 60774010 60806205 60821878 60900890 60929076 60940011 60977427 61002171 61052831 61099153 61099154 61160412 61179797 61224841 61322982 61350125 61401716 61401717 61462911 61462913 61530676 61570273 61603865 61687779 61708127 61713703 61722607 61758469 61801237 61833353 61864132 61866011 61895531 61916496 61957514 61977936 62038437 62082442 369079 60109633 60118609 60134080 60150445 60176106 60192051 60222094 60233948 60246462 60258491 60266068 60308808 60323676 60340824 60403880 60471631 60476821 60499750 60541843 60620064 60713450 60747325 60785563 60807552 60847642 60873346 60900892 60910706 60940012 61002173 61099155 61160414 61160415 61179798 61256819 61304717 61368509 61437326 61462915 61502827 61530677 61570272 61603867 61618476 61687780 61713706 61738926 61780617 61808406 61839881 61887183 61895530 61916497 61957513 61977937 62038438 62082443 62094970 62135049 60115229 60147972 60187378 60222126 60265911 60294575 60392806 60476823 60541848 60614467 60686888 60780548 60847640 60940013 61002175 61160421 61195075 61256821 61350133 61530675 61713705 61722597 61808409 61911473 61977938 62082444 62094971 62185963 60780548R 366156 60115230 60128961 60192052 60240138 60247732 60340823 60392807 60476825 60499751 60578145 60671486 60780549 60940014 61052832 61168324 61179799 61304723 61555312 61708128 61780616 61833354 61957515 62065295 62185964 60499751R 60785642 60821890 60174804 60822260 60906848 60174805 60300570 60817944 60906849 61140356 366080 366236 60118941 60174806 60242544 60308818 60536314 60714974 60806206 60906850 61077113 61224843 366091 366247 366405 369906 60089257 60134699 60150864 60183062 60194913 60197943 60234289 60247730 60262544 60272088 60305872 60308819 60451048 60536318 60651986 60687043 60728081
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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