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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 7

Device Problems
No code available 58
Other (for use when an appropriate device code cannot be identified) 46
No Known Device Problem 32
Foreign material present in device 29
No Information 17
Device operates differently than expected 9
Unknown (for use when the device problem is not known) 9
Reaction 7
Improper or incorrect procedure or method 6
Crack 5
Use of Device Issue 5
Break 4
Absorption 3
Material integrity issue 3
Incorrect device or component shipped 2
Device markings issue 2
Tear, rip or hole in device packaging 2
Material fragmentation 2
Migration of device or device component 2
Delivered as unsterile product 1
Particulates 1
Incorrect or inadequate result 1
Material separation 1
Sticking 1
Tidal volume fluctuations 1
Dent in material 1
Delivery System Issue, No Description 1
Patient-device incompatibility 1
Failure to Adhere or Bond 1
Incomplete or missing packaging 1
Total Device Problems 254

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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