FDAFDA · Food and drugs·Recall number Z-2596-2017
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM FEM IM NAIL 13MMDX40CM FEM IM NAIL 14MMDX40CM FEM IM NAIL 15MMDX40CM FEM IM NAIL 11MMDX42CM FEM IM NAIL 12MMDX42CM FEM IM NAIL 13MMDX42CM FEM IM NAIL 14MMDX42CM FEM IM NAIL 15MMDX42CM FEM IM NAIL 11MMDX44CM FEM IM NAIL 12MMDX44CM FEM IM NAIL 13MMDX44CM FEM IM NAIL 14MMDX44CM FEM IM NAIL 10MMDX46CM FEM IM NAIL 11MMDX46CM FEM IM NAIL 12MMDX46CM FEM IM NAIL 13MMDX46CM FEM IM NAIL 14MMDX46CM FEM IM NAIL 10MMDX48CM FEM IM NAIL 11MMDX48CM FEM IM NAIL 12MMDX48CM FEM IM NAIL 13MMDX48CM FEM IM NAIL 14MMDX48CM FEM IM NAIL 13MMDX50CM FEM IM NAIL 14MMDX50CM
Published June 21, 2017 · Recall initiated: April 28, 2017
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 Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below
- Lot
- Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012 00225242013 00225242014 00225242015 00225244011 00225244012 00225244013 00225244014 00225246010 00225246011 00225246012 00225246013 00225246014 00225248010 00225248011 00225248012 00225248013 00225248014 00225250013 00225250014 Lot Numbers: 60684923 60680624 60680627 60680627R 60680623 60680623R 60680629 60680629R 60680615 60680628 60680615R 60680628R 60680625 60680619 60680619R 60691710 60691708 60691713 60691708R 60732923 60732923R 60691711 60732925 60745751 60691711R 60745751R 60732924 60747393 60747393R 367355 60753357 367355R 60753357R 60721966 60747408 60721966R 367348 60751917 60751917R 60753355 60753356 60758098 60753355R 60715104 60758099 60735584 60735585 60735585R 367352 60789431 60789432 60789431R 367354 60747405 60797046 60797046R 60789429 60789429R 60691709 60789426 60789428 60691709R 60807362 60807365 60807366 60807376 60807376R 60807359 60817729 60817730 60817731 60817733 60817730R 60817733R 367739 367739R 367737 60817725 60817727 367737R 60817727R 60822101 60822112 60822112R 60821407 60822113 60821407R 367749 367749R 60822105 60822106 60822107 60822106R 60822107R 60822102 60822102R 60821408 60827839 60827840 60827839R 60827840R 60836675 367751 60828364 367750 367752 60836673 367750R 367766 367767 367779 367766R 60836664 60836664R 60828363 60833614 60833960 60836676 60838315 60838317 60843576 60833614R 60838315R 60843576R 60833622 60843575 60827843 60833609 60836659 60836670 60836679 60836680 60838316 60827843R 60836659R 367753 60827844 60828362 60830568 60843574 60844203 60844204 60848502 367753R 60827844R 60844203R 60844204R 60848502R 60829849 60838314 60848496 60848497 60848504 60848497R 60836677 60848508 60854060 60836677R 60848508R 60854049 367781 60854056 60854057 60854056R 60854057R 60854050 60854061 60854061R 60854051 60854058 60854058R 367881 60854052 60854071 60854072 60859070 60859073 60854052R 60854071R 60854072R 60859070R 60859073R 367878 367878R 60844202 60854055 60874456 60854055R 60874456R 367882 367882R 60859067 60859067R 367877 368034 367983 368221 368224 368230 368341 368224R 368069 368069R 368223 60885947 60885949 60885947R 60885949R 60885951 60885951R 368231 60893397 367985 367985R 367984 368032 368033 368042 368208 368213 368225 368477 368225R 368041 368070 368206 367986 367986R 60919007 60919007R 60859072 60919010 60836674 60925352 60836674R 60925352R 368872 60931434 60931435 60931437 60931438 60937694 368854 368854R 368869 368869R 368843 368853 368900 368900R 368811 368839 368811R 368839R 368851 368859 368867 368873 368867R 368873R 368838 368846 368858 368846R 368832 368840 368852 368866 368868 368832R 368852R 368868R 368812 368830 368844 368847 368862 368865 368847R 368862R 368861 61018709 61023630 60984608 61023622 61023623 61023624 61023631 61023623R 369074 60984611 60984611R 369061 369071 369067 369072 61018710 61049120 61049121 61049122 369062 369070 61049135 61049136 61049119 61075885 61075885R 61069827 369066 368845 61069825 61085256 61085258 61085259 61069825R 61085255 61049654 61049654R 369182 369179 61114064 61117739 61117742 61114065 61114063 61114072 61114073 61120894 61133012 61092440 61147965 61147978 61114071 61147973 61147975 61114071R 61147970 61143357 61143358 61164612 61164612R 61117741 61147971 61147974 61147976 61147977 61151161 61151162 61159192 61159193 61164613 61147971R 61147977R 61151162R 61159192R 61175871 61175871R 61175872 61184353 61175872R 61
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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