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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device washer, bolt nut
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHTN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 10
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LINVATEC
  1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 2
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5
TRIAGE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 13
Break 6
Migration of device or device component 3
No code available 3
Unintended movement 2
No Information 2
Implant, removal of 2
Difficult to remove 2
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Device, or device fragments remain in patient 1
Component(s), broken 1
Fracture 1
Material fragmentation 1
Loss of osseointegration 1
Malfunction 1
Failure to align 1
Failure to separate 1
Device operates differently than expected 1
Mechanical jam 1
Total Device Problems 45

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 0 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

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