INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
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
- 60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817 60387525 60569948 60602446 60620341 60630482 60711126 60714151 60735643 60808002 60819266 60864018 60864019 60876889 60876890 60956565 61104687 61112613 61133165 61266235 61422229 61458906 61489975 60690743 60711143 60714152 60728336 60735644 60747675 60757046 60789824 60808003 60817590 60838120 60838121 60876892 60876893 60937495 60937496 61031038 61112614 61112651 61158629 61161384 60466661 60615939 60735645 60817572 60847807 61120278 61221431 61263174 61333468 60152966 60196077 60196079 60750994 60806391 60847809 60979630 61226089 61263175 61408290 61504079 60753364 60806396 60817586 60829585 60876926 60931129 61331079 60120568 60140390 60150071 60152967 60165627 60177186 60185172 60190843 60195440 60195442 60243126 60253766 60279638 60279639 60279640 60338431 60349085 60387526 60393389 60422609 60438317 60444815 60472686 60528779 60569949 60602447 60602448 60620342 60653343 60690744 60714153 60735646 60735647 60735648 60811023 60819429 60819430 60864026 60864029 60876928 60937499 60937501 60979623 60985453 61079807 61079808 61086366 61100812 61104688 61140198 61143244 61150035 61161407 61173560 61194688 61231196 61244342 61280079 61293775 61303278 61319424 61383085 61428464 61453389 61516672 61564740 61613173 61657631 61709056 61709069 61763484 60103523 60127531 60130218 60140391 60152968 60172506 60179290 60201128 60201130 60229987 60242009 60265708 60279641 60323303 60323305 60338432 60349086 60387527 60393390 60407650 60438318 60444317 60491698 60569950 60602207 60620343 60653345 60653346 60690745 60714154 60735649 60735650 60808004 60819270 60819273 60864032 60864034 60956555 60956558 60956566 60956567 61064852 61075702 61086367 61100813 61104689 61120279 61143245 61158631 61164107 61173035 61173562 61173564 61173565 61512411 61729530 61763487 60349309 60602449 60674160 60690747 60714155 60735652 60757049 60808006 60814361 60829589 60829590 60876895 60876897 60937502 60937503 60966581 61067793 61112652 61158633 61161356 61190345 60615916 60735653 60745777 60806394 60819279 60876929 60926469 61150072 61150073 61202901 61224266 61231239 61238805 61349139 61356914 61383087 61428466 61489976 61496668 61516673 60109571 60367539 60407652 60597682 60653348 60735654 60814200 60847818 60857999 61120979 61140199 61226092 61263176 61267707 61434739 62326518 60117045 60135211 60145198 60157582 60177187 60185173 60186867 60208631 60242010 60253767 60253768 60279642 60279643 60279646 60338433 60338434 60349087 60349088 60461528 60461529 60487153 60517097 60517098 60537305 60537306 60550321 60569954 60572975 60575720 60602450 60620364 60653349 60674184 60735655 60735657 60811024 60819285 60819286 60819287 60876931 60876934 60937497 60937498 60979626 60985463 61059954 61096522 61100814 61104691 61131925 61256012 61263177 61267708 61475183 61484475 61547943 61555829 61564741 61597005 61664932 61729533 60097908 60099562 60107380 60114655 60115159 60117047 60123301 60124858 60130219 60135212 60135213 60142917 60145199 60145201 60152969 60154189 60157583 60165630 60167143 60172507 60177188 60177190 60186868 60186869 60189042 60193856 60196080 60196081 60196082 60201133 60201134 60218842 60218843 60218844 60229988 60239641 60242011 60242012 60259288 60259290 60265709 60265710 60265711 60279652 60279654 60279655 60279656 60309136 60309138 60323307 60323308 60323309 60338435 60338436 60338437 60338438 60349089 60349090
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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