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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dispenser, cement
Regulation Description Cement dispenser.
Product CodeKIH
Regulation Number 888.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 17
Break 10
Other (for use when an appropriate device code cannot be identified) 2
Malfunction 2
No Known Device Problem 2
No code available 2
Loss of or failure to bond 1
Device, removal of (non-implant) 1
Device Issue 1
Fire 1
Foreign material 1
Device, or device fragments remain in patient 1
Tip breakage 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 BIOMET FRANCE S.A.R.L. II Jun-10-2015
2 Orthovita, Inc. II Sep-12-2011
3 Orthovita, Inc., dBA Stryker Orthobiologics. II Sep-16-2015
4 Stryker Instruments Div. of Stryker Corporation II Mar-12-2012

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