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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeLXT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 6
IMMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 5
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 9
SYNTHES
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Implant, removal of 82
No Information 40
Unknown (for use when the device problem is not known) 37
No code available 28
Difficult to insert 27
Mechanical issue 24
Break 19
Fracture 15
Malfunction 13
Other (for use when an appropriate device code cannot be identified) 13
No Known Device Problem 6
Failure to separate 5
Improper or incorrect procedure or method 5
Loose 5
Migration of device or device component 4
Device remains implanted 4
Disengaged 3
Malposition of device 3
Fitting problem 2
Size incorrect for patient 2
Defective component 2
Material integrity issue 2
Disassembly 2
Replace 1
Device abrasion from instrument or another object 1
Displacement 1
Explanted 1
Failure to Adhere or Bond 1
Bent 1
Component(s), broken 1
Detachment of device component 1
Crack 1
Mechanical jam 1
Cable, defective 1
Unintended movement 1
Metal shedding debris 1
Device markings issue 1
Device or device component damaged by another device 1
Foreign material present in device 1
Total Device Problems 359

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-08-2016
2 Biomet, Inc. II Apr-14-2015
3 Orthofix, Inc II Feb-26-2008
4 Zimmer Inc. II Jun-30-2009

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