NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLUTED STEM EXT, 2 NEXGEN CEMENTED STEM EXT
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
- 61424993 61507222 61543969 61442278 61497511 61518148 61518149 61627190 61454951 61454952 61507223 61558358 61627192 61627198 61627202 61643930 61721669 61442310 61459958 61475125 61543975 61567342 61627206 61678232 61678233 61442319 61454955 61459970 61475130 61518182 61543977 61567344 61627260 61658886 61414605 61451226 61479488 61479489 61479490 61518197 61518198 61592093 61643938 61682157 61685470 61721675 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61424999 61543980 60877120 60893096 60903660 60917693 60917702 60917706 60917708 60917709 60917710 60917711 60917712 60917713 60918890 60918891 60918895 60918896 60918898 60918899 60922337 60922338 60922340 60922341 60922342 60922343 60922345 60922347 60922348 60927295 60927296 60927297 60927299 60927301 60927302 60927303 60927304 60927305 60927307 60927310 60927311 60931982 60931984 60936965 60936970 60936971 60936972 60936975 60936977 60936978 60947334 60947335 60954602 60966905 60966909 60966911 60966916 60966917 60966918 60973395 60973396 60973397 60973412 60973414 60983508 60983509 60983511 60983518 60983519 60983537 60983538 60983541 60983543 60983546 60994064 60994065 60995223 60995226 60995227 60998606 60998607 60998608 60998610 60998612 60998614 60998615 60998616 61010638 61010641 61010642 61010643 61010644 61010645 61010648 61010649 61010650 61010651 61010652 61010653 61014247 61014249 61014250 61014252 61014255 61021221 61021224 61021225 61021226 61021227 61021228 61021230 61021306 61021307 61021308 61021312 61021316 61021320 61035495 61035498 61035502 61035504 61038490 61038493 61038494 61038495 61038497 61038498 61040924 61040926 61040931 61040934 61040935 61048572 61048578 61048579 61048586 61048589 61048594 61048596 61048601 61048602 61058838 61058847 61059230 61069102 61069106 61069107 61069108 61069109 61069112 61069118 61069120 61076460 61076464 61076466 61076469 61078108 61078111 61078114 61078117 61078119 61078123 61078125 61092972 61092977 61092983 61102691 61102693 61102694 61102696 61108056 61108061 61108062 61108065 61112912 61112913 61112917 61119367 61119370 61119372 61119374 61124789 61124798 61124804 61124805 61131271 61131276 61132842 61132844 61132845 61132849 61132853 61140579 61150275 61150277 61150281 61159982 61159983 61159988 61159999 61160000 61160001 61160003 61160005 61167721 61167722 61167723 61167733 61167734 61179424 61179425 61184213 61184214 61184217 61184261 61184266 61197244 61197245 61197247 61199763 61199769 61199771 61211931 61211933 61211937 61211941 61211943 61218919 61218920 61218925 61223776 61223780 61223782 61223790 61223791 61223796 61223805 61223832 61242447 61242449 61242456 61242457 61242462 61242474 61242475 61242476 61257174 61257175 61257176 61257183 61258774 61258777 61264922 61267060 61267063 61267064 61267066 61269358 61269363 61280348 61284049 61284056 61287945 61287952 61293458 61296649 61296650 61296653 61309294 61311710 61311713 61311716 61311719 61314458 61314464 61320957 61320959 61320961 61320964 61320990 61321001 61321003 61323883 61323884 61323888 61323893 61323895 61323897 61323903 61335436 61335437 61335438 61335444 61339662 61339663 61339665 61339666 61339669 61339674 61341414 61347407 61347409 61347410 61347416 61347417 61351245 61351250 61351253 61351257 61357757 61357759 61357761 61357765 61363078 61363082 61368391 61368393 61368404 61378334 61378336 61378341 61378342 61380586 61380588 61380590 61387982 61387988 61387989 61387991 61390873 61390874 61390877 61390880 61390883 61390886 61390887 61390888 61397071 61397075 61397078 61401463 61401467 61406477 61406478 61406479 61417036
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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