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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agent, absorbable hemostatic, collagen based
Regulation Description Absorbable hemostatic agent and dressing.
Product CodeLMF
Regulation Number 878.4490
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
22 11 11 14 11 14 33 35 22 15 0

Device Problems
Other (for use when an appropriate device code cannot be identified) 46
No code available 35
No Known Device Problem 26
Foreign material present in device 21
No Information 17
Unknown (for use when the device problem is not known) 9
Device operates differently than expected 8
Reaction 7
Improper or incorrect procedure or method 6
Use of Device Issue 4
Absorption 3
Break 3
Material integrity issue 3
Material fragmentation 2
Migration of device or device component 2
Tear, rip or hole in device packaging 2
Dent in material 1
Delivery System Issue, No Description 1
Device markings issue 1
Failure to Adhere or Bond 1
Particulates 1
Material separation 1
Sticking 1
Tidal volume fluctuations 1
Total Device Problems 202

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 1 0 0 0 0 0
Class II 0 1 0 0 0 3 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Bioscience II Sep-20-2008
2 Ethicon, Inc. I Nov-16-2012
3 Ethicon, Inc. II Jun-27-2012
4 Integra LifeSciences Corporation II May-10-2013
5 Stryker Orthobiologics, Inc. II Nov-22-2012
6 Superstat Corp II Nov-16-2012

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