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U.S. Department of Health and Human Services

Class 2 Device Recall Radiesse

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 Class 2 Recall
Radiesse
see related information
Date Posted November 01, 2011
Recall Status1 Terminated on May 01, 2012
Recall Number Z-0145-2012
Recall Event ID 60046
Premarket Approval
PMA Numbers
P050037 P050052
Product Classification Implant, Dermal, For Aesthetic Use - Product Code LMH
Product MERZ AESTHETICS, Radiesse® Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.
Code Information Item Lot # 8071M0H1 1018162 8071M0H1 1018863 8071M0H1 1019314 8071M0H1 1023474 8071M0H1 1023492 8071M0H1 1023887 8071M0H1 1024580 8071M0H1 1025106 8071M0K1 1017325 8071M0K1 1017326 8071M0K1 1017327 8071M0K1 1017328 8071M0K1 1017329 8071M0K1 1017570 8071M0K1 1017571 8071M0K1 1017572 8071M0K1 1017573 8071M0K1 1017580 8071M0K1 1017581 8071M0K1 1017582 8071M0K1 1017583 8071M0K1 1017584 8071M0K1 1017659 8071M0K1 1017660 8071M0K1 1017661 8071M0K1 1017662 8071M0K1 1017663 8071M0K1 1017664 8071M0K1 1017665 8071M0K1 1017666 8071M0K1 1017667 8071M0K1 1017668 8071M0K1 1017669 8071M0K1 1017670 8071M0K1 1017671 8071M0K1 1017672 8071M0K1 1017673 8071M0K1 1017674 8071M0K1 1017760 8071M0K1 1017761 8071M0K1 1017762 8071M0K1 1017763 8071M0K1 1017764 8071M0K1 1017765 8071M0K1 1017766 8071M0K1 1017799 8071M0K1 1017800 8071M0K1 1017801 8071M0K1 1017802 8071M0K1 1017803 8071M0K1 1017804 8071M0K1 1017805 8071M0K1 1017813 8071M0K1 1017939 8071M0K1 1017940 8071M0K1 1017941 8071M0K1 1017942 8071M0K1 1017943 8071M0K1 1017944 8071M0K1 1017964 8071M0K1 1017965 8071M0K1 1017966 8071M0K1 1017967 8071M0K1 1017968 8071M0K1 1017969 8071M0K1 1017970 8071M0K1 1017971 8071M0K1 1018039 8071M0K1 1018040 8071M0K1 1018041 8071M0K1 1018042 8071M0K1 1018059 8071M0K1 1018060 8071M0K1 1018061 8071M0K1 1018156 8071M0K1 1018157 8071M0K1 1018158 8071M0K1 1018159 8071M0K1 1018160 8071M0K1 1018170 8071M0K1 1018171 8071M0K1 1018172 8071M0K1 1018230 8071M0K1 1018231 8071M0K1 1018232 8071M0K1 1018233 8071M0K1 1018234 8071M0K1 1018235 8071M0K1 1018236 8071M0K1 1018237 8071M0K1 1018238 8071M0K1 1018239 8071M0K1 1018240 8071M0K1 1018241 8071M0K1 1018246 8071M0K1 1018247 8071M0K1 1018248 8071M0K1 1018249 8071M0K1 1018250 8071M0K1 1018251 8071M0K1 1018252 8071M0K1 1018253 8071M0K1 1018254 8071M0K1 1018255 8071M0K1 1018262 8071M0K1 1018263 8071M0K1 1018264 8071M0K1 1018265 8071M0K1 1018408 8071M0K1 1018409 8071M0K1 1018410 8071M0K1 1018411 8071M0K1 1018412 8071M0K1 1018413 8071M0K1 1018425 8071M0K1 1018426 8071M0K1 1018427 8071M0K1 1018428 8071M0K1 1018429 8071M0K1 1018430 8071M0K1 1018547 8071M0K1 1018548 8071M0K1 1018549 8071M0K1 1018551 8071M0K1 1018552 8071M0K1 1018553 8071M0K1 1018562 8071M0K1 1018563 8071M0K1 1018564 8071M0K1 1018565 8071M0K1 1018580 8071M0K1 1018581 8071M0K1 1018582 8071M0K1 1018583 8071M0K1 1018676 8071M0K1 1018677 8071M0K1 1018678 8071M0K1 1018679 8071M0K1 1018693 8071M0K1 1018694 8071M0K1 1018695 8071M0K1 1018696 8071M0K1 1018711 8071M0K1 1018712 8071M0K1 1018713 8071M0K1 1018726 8071M0K1 1018727 8071M0K1 1018728 8071M0K1 1018732 8071M0K1 1018733 8071M0K1 1018734 8071M0K1 1018852 8071M0K1 1018853 8071M0K1 1018854 8071M0K1 1018855 8071M0K1 1018858 8071M0K1 1018859 8071M0K1 1018860 8071M0K1 1018861 8071M0K1 1018862 8071M0K1 1018866 8071M0K1 1018867 8071M0K1 1018868 8071M0K1 1018869 8071M0K1 1018870 8071M0K1 1018871 8071M0K1 1018872 8071M0K1 1018873 8071M0K1 1018880 8071M0K1 1018881 8071M0K1 1018882 8071M0K1 1018883 8071M0K1 1018884 8071M0K1 1018885 8071M0K1 1018886 8071M0K1 1018887 8071M0K1 1019035 8071M0K1 1019036 8071M0K1 1019037 8071M0K1 1019038 8071M0K1 1019040 8071M0K1 1019041 8071M0K1 1019042 8071M0K1 1019166 8071M0K1 1019167 8071M0K1 1019168 8071M0K1 1019169 8071M0K1 1019175 8071M0K1 1019176 8071M0K1 1019177 8071M0K1 1019178 8071M0K1 1019193 8071M0K1 1019194 8071M0K1 1019195 8071M0K1 1019196 8071M0K1 1019197 8071M0K1 1019198 8071M0K1 1019300 8071M0K1 1019301 8071M0K1 1019330 8071M0K1 1019331 8071M0K1 1020104 8071M0K1 1020105 8071M0K1 1022191 8071M0K1 1022192 8071M0K1 1022193 8071M0K1 1022194 8071M0K1 1022195 8071M0K1 1022196 8071M0K1 1022209 8071M0K1 1022435 8071M0K1 1022436 8071M0K1 1022452 8071M0K1 1022453 8071M0K1 1022454 8071M0k1 1022455 8071M0K1 1022570 8071M0K1 1022572 8071M0K1 1022573 8071M0K1 1022574 8071M0K1 1022575 8071M0K1 1022632 8071M0K1 1022712 8071M0K1 1022713 8071M0K1 1022714 8071M0K1 1022715 8071M0K1 1022716 8071M0K1 1022717 8071M0K1 1022747 8071M0K1 1022748 8071M0K1 1022749 8071M0K1 1022750 8071M0K1 1022751 8071M0K1 1022896 8071M0K1 1022897 8071M0K1 1022898 8071M0K1 1022899 8071M0K1 1022900 8071M0K1 1022901 8071M0K1 1022902 8071M0K1 1022903 8071M0k1 1022960 8071M0K1 1022961 8071M0K1 1022962 8071M0K1 1022963 8071M0K1 1022964 8071M0K1 1022982 8071M0K1 1022983 8071M0K1 1022984 8071M0K1 1022985 8071M0K1 1022986 8071M0K1 1022987 8071M0K1 1022988 8071M0K1 1022989 8071M0K1 1022990 8071M0K1 1022991 8071M0K1 1022992 8071M0K1 1022993 8071m0k1 1022994 8071M0K1 1022995 8071M0K1 1023076 8071M0K1 1023077 8071M0K1 1023078 8071M0K1 1023079 8071M0K1 1023080 8071M0K1 1023081 8071M0K1 1023082 8071M0K1 1023083 8071M0K1 1023084 8071M0K1 1023085 8071M0K1 1023173 8071M0K1 1023174 8071M0K1 1023175 8071M0K1 1023181 8071M0K1 1023182 8071M0K1 1023183 8071M0K1 1023184 8071M0K1 1023185 8071M0K1 1023186 8071M0K1 1023187 8071M0K1 1023188 8071M0K1 1023304 8071M0K1 1023305 8071M0K1 1023306 8071M0K1 1023307 8071M0K1 1023308 8071M0K1 1023309 8071M0K1 1023310 8071M0K1 1023311 8071M0K1 1023312 8071M0K1 1023313 8071M0K1 1023314 8071M0K1 1023315 8071M0K1 1023316 8071M0K1 1023317 8071M0K1 1023475 8071M0k1 1023476 8071M0K1 1023493 8071M0K1 1023494 8071M0K1 1023495 8071M0K1 1023496 8071M0K1 1023497 8071M0K1 1023498 8071M0K1 1023499 8071M0K1 1023500 8071M0K1 1023508 8071M0K1 1023509 8071M0K1 1023600 8071M0K1 1023601 8071M0K1 1023602 8071M0K1 1023603 8071M0K1 1023634 8071M0K1 1023643 8071m0k1 1023644 8071M0K1 1023645 8071M0K1 1023646 8071M0K1 1023647 8071M0K1 1023648 8071M0K1 1023649 8071M0K1 1023650 8071M0K1 1023651 8071M0K1 1023652 8071M0K1 1023653 8071M0K1 1023654 8071M0K1 1023734 8071M0K1 1023735 8071M0K1 1023736 8071M0K1 1023737 8071M0K1 1023738 8071M0K1 1023753 8071M0K1 1023881 8071M0K1 1023882 8071M0K1 1023883 8071M0K1 1023884 8071M0K1 1023885 8071M0K1 1023886 8071M0K1 1023888 8071M0K1 1023889 8071M0K1 1023890 8071M0K1 1023978 8071M0k1 1023979 8071M0k1 1023980 8071M0K1 1023981 8071M0K1 1023982 8071M0K1 1024005 8071M0K1 1024006 8071M0K1 1024007 8071M0K1 1024008 8071M0K1 1024009 8071M0K1 1024118 8071M0K1 1024119 8071M0K1 1024120 8071M0K1 1024121 8071M0K1 1024122 8071M0K1 1024123 8071M0K1 1024124 8071M0K1 1024125 8071M0K1 1024140 8071M0K1 1024141 8071M0K1 1024142 8071M0K1 1024143 8071M0K1 1024144 8071M0K1 1024145 8071M0K1 1024146 8071M0K1 1024147 8071M0K1 1024148 8071m0k1 1024149 8071M0K1 1024150 8071M0K1 1024254 8071M0K1 1024255 8071M0K1 1024256 8071M0K1 1024257 8071M0K1 1024258 8071M0K1 1024259 8071M0K1 1024260 8071M0K1 1024261 8071M0K1 1024262 8071M0K1 1024263 8071M0K1 1024264 8071M0k1 1024395 8071M0K1 1024396 8071M0K1 1024397 8071M0K1 1024398 8071M0K1 1024399 8071M0K1 1024400 8071M0K1 1024401 8071M0K1 1024402 8071M0K1 1024567 8071M0k1 1024568 8071M0K1 1024569 8071M0K1 1024610 8071M0K1 1024611 8071M0k1 1024612 8071M0K1 1024741 8071M0K1 1024749 8071M0K1 1024863 8071M0K1 1024864 8071M0K1 1024865 8071M0K1 1024866 8071M0K1 1024999 8071M0K1 1025107 8071M0K1 1025108 8071M0k1 1025109 8071M0K1 1025110 8071M0K1 1025111 8071M0K1 1025112 8071M0K1 1025113 8071M0K1 1025122 8071M0K1 1025123 8071M0K1 1025124 8071M0k1 1025125 8071M0K1 1025126 8071M0K1 1025127 8071M0K1 1025128 8071M0K1 1025129 8071M0K1 1025130 8071M0k1 1025131 8071M0K1 1025132 8071M0K1 1025133 8071M0K1 1025134 8071M0K1 1025135 8071M0K1 1025136 8071M0K1 1025138 8071M0K1 1025917 8071M0K1 1025918 8071M0K1 1025919 8071M0K1 1025920 8071M0K1 1025932 8071M0K1 1025933 8071M0K1 1025934 8071M0K1 1025935 8071M0K1 1025936 8071M0K1 1025941 8071M0K1 1025989 8071M4K1 1017460 8071M4K1 1018062 8071M4K1 1018270 8071M4K1 1019039 8071M4K1 1020026 8071M4K1 1020027 8071M4K1 1023765 8071M4K1 1023766 8071M4K1 1023767 8071M5 1017341 8071M5 1017342 8071M5 1017343 8071M5 1017344 8071M5 1017345 8071M5 1017574 8071M5 1017818 8071M5 1017819 8071M5 1017820 8071M5 1017821 8071M5 1017822 8071M5 1017823 8071M5 1017935 8071M5 1017936 8071M5 1017937 8071M5 1017938 8071M5 1017960 8071M5 1017961 8071M5 1017962 8071M5 1017963 8071M5 1018063 8071M5 1018064 8071M5 1018065 8071M5 1018066 8071M5 1018163 8071M5 1018164 8071M5 1018165 8071M5 1018167 8071M5 1018168 8071M5 1018169 8071M5 1018266 8071M5 1018267 8071M5 1018268 8071M5 1018401 8071M5 1018402 8071M5 1018545 8071M5 1018546 8071M5 1018566 8071M5 1018567 8071M5 1018584 8071M5 1018585 8071M5 1018586 8071M5 1018587 8071M5 1018714 8071M5 1018715 8071M5 1019043 8071M5 1019044 8071M5 1019045 8071M5 1019046 8071M5 1019047 8071M5 1019048 8071M5 1019173 8071M5 1019174 8071M5 1019191 8071M5 1019192 8071M5 1019315 8071M5 1019316 8071M5 1019317 8071M5 1019318 8071M5 1022444 8071M5 1022752 8071M5 1022753 8071M5 1022754 8071M5 1022755 8071M5 1022756 8071M5 1022757 8071M5 1022965 8071M5 1022966 8071M5 1022967 8071M5 1022968 8071M5 1022969 8071M5 1023075 8071M5 1023468 8071M5 1023469 8071M5 1023478 8071M5 1023479 8071M5 1023480 8071M5 1023481 8071M5 1023490 8071M5 1023491 8071M5 1023503 8071M5 1023504 8071M5 1023505 8071M5 1023506 8071M5 1023510 8071M5 1023511 8071M5 1023512 8071M5 1023596 8071M5 1023597 8071M5 1023598 8071M5 1023599 8071M5 1023754 8071M5 1023755 8071M5 1023756 8071M5 1023757 8071M5 1023906 8071M5 1023907 8071M5 1023908 8071M5 1023909 8071M5 1023910 8071M5 1023911 8071M5 1023973 8071M5 1023974 8071M5 1023975 8071M5 1023976 8071M5 1023977 8071M5 1024000 8071M5 1024001 8071M5 1024002 8071M5 1024003 8071M5 1024004 8071M5 1024126 8071M5 1024127 8071M5 1024128 8071M5 1024129 8071M5 1024130 8071M5 1024131 8071M5 1024132 8071M5 1024151 8071M5 1024152 8071M5 1024153 8071M5 1024154 8071M5 1024267 8071M5 1024268 8071M5 1024269 8071M5 1024270 8071M5 1024271 8071M5 1024272 8071M5 1024273 8071M5 1024403 8071M5 1024404 8071M5 1024405 8071M5 1024406 8071M5 1024407 8071M5 1024408 8071M5 1024409 8071M5 1024540 8071M5 1024541 8071M5 1024542 8071M5 1024613 8071M5 1024710 8071M5 1024711 8071M5 1024740 8071M5 1024741 8071M5 1024742 8071M5 1024743 8071M5 1025657 8071M5 1025928 8071M5 1025929 8071M5 1025930 8071M5 1025931 8071M9 1022558 8071M9 1022559 8071M9 1022560 8071M9 1022561 8071M9 1022562 8071M9 1022563 8071M9 1022564 8071M9 1022565 8071M9 1022566 8071M9 1022567 8071M9 1022568 8071M9 1022569 8071M9 1023329 8071M9 1023330 8071M9 1023331 8071M9 1023332 8071M9 1023333 8071M9 1023334 8071M9 1023335 8071M9 1023336 8071M9 1023337 8071M9 1023482 8071M9 1023483 8071M9 1023484 8071M9 1023912 8071M9 1023913 8071M9 1024559 8071M9 1024560 8071M9 1024561 8071M9 1024562 8071M9 1024563 8071M9 1024564 8071M9 1024604
Recalling Firm/
Manufacturer
Merz Aesthetics, Inc.
4133 Courtney Rd Ste 10
Franksville, Wisconsin 53126-9127
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 8/18/11, consignees were sent a Merz Aesthetics "Urgent Medical Device Recall" letter dated August 15, 2011. The letter was addressed to "Dear Health Care Professional". The letter described the product and the problem and listed the details regarding this issue.
Quantity in Commerce 311,582
Distribution Worldwide distribution including USA, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMH and Applicant = BIOFORM MEDICAL, INC.
PMAs with Product Code = LMH and Applicant = MERZ AESTHETICS, INC.
PMAs with Product Code = LMH and Applicant = MERZ NORTH AMERICA, INC
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