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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 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 102257
Recalling Firm/
Manufacturer
Merz Aesthetics, Inc.
4133 Courtney Rd Ste 10
Franksville WI 53126-9127
262-286-4025
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 = BIOFORM MEDICAL, INC.
PMAs with Product Code = LMH and Original Applicant = MERZ AESTHETICS, INC.
PMAs with Product Code = LMH and Original Applicant = MERZ NORTH AMERICA, INC
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