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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
22 12 11 16 14 15 8

Device Problems
Other (for use when an appropriate device code cannot be identified) 46
No Information 12
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
Absorption 3
Migration of device or device component 2
Device operates differently than expected 2
Foreign material present in device 1
Failure to Adhere or Bond 1
Material fragmentation 1
Sticking 1
Delivery System Issue, No Description 1
Total Device Problems 94

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