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U.S. Department of Health and Human Services

Class 2 Device Recall Radiesse

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 Class 2 Device 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
PMA Number 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 5
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
8
Recalling Firm/
Manufacturer
Merz Aesthetics, Inc.
4133 Courtney Rd Ste 10
Franksville WI 53126-9127
For Additional Information Contact
262-286-4025
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
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 Original Applicant = MERZ NORTH AMERICA, INC
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