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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device condylar plate fixation implant
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDP
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 59
Break 29
Unintended movement 7
Migration of device or device component 4
Fitting problem 2
Dislodged or dislocated 2
Bent 2
Material deformation 1
Malfunction 1
Device operates differently than expected 1
Total Device Problems 108

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 0 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Synthes USA HQ, Inc. II Nov-26-2013
2 Synthes, Inc. II Mar-04-2014

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