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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 Initiated by Firm August 18, 2011
Date Posting Updated November 01, 2011
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LMH and Original Applicant = MERZ NORTH AMERICA, INC
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