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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, dermal, for aesthetic use
Product CodeLMH
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
15 50 37 19 21 44 39 61 60 42

Device Problems
No Known Device Problem 2196
Migration of device or device component 77
Needle, separation 46
Spillage, accidental 40
Improper or incorrect procedure or method 26
No Information 10
Detachment of device or device component 9
Foreign material present in device 6
Patient-device incompatibility 5
Not Applicable 5
Use of Device Issue 3
Break 3
Biofilm coating in device 2
Dislodged or dislocated 2
Expulsion 2
Material integrity issue 1
Aspiration issue 1
Device operates differently than expected 1
No code available 1
Operating system becomes non-functional 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Invalid sensing 1
Malposition of device 1
Delivered as unsterile product 1
Occlusion within device 1
Unsealed device packaging 1
Particulates 1
User used incorrect product for intended use 1
Shelf life exceeded 1
Total Device Problems 2447

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 1 0 0 0 2 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Enhancement Medical, LLC I Aug-08-2014
2 Merz Aesthetics, Inc. II Nov-01-2011
3 Merz Aesthetics, Inc. III May-19-2011
4 Merz North America, Inc. II Dec-03-2015
5 Orthovita, Inc., dBA Stryker Orthobiologics. II Mar-30-2015

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