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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
22 11 11 14 11 14 33 35 22 7

Device Problems
Other (for use when an appropriate device code cannot be identified) 46
No Known Device Problem 22
No code available 21
No Information 16
Foreign material present in device 10
Unknown (for use when the device problem is not known) 9
Reaction 7
Use of Device Issue 4
Improper or incorrect procedure or method 4
Device operates differently than expected 4
Material integrity issue 3
Absorption 3
Break 2
Material fragmentation 2
Migration of device or device component 2
Particulates 1
Material separation 1
Sticking 1
Tidal volume fluctuations 1
Failure to Adhere or Bond 1
Tear, rip or hole in device packaging 1
Delivery System Issue, No Description 1
Total Device Problems 162

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