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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 19
Break 18
Fracture 15
Other (for use when an appropriate device code cannot be identified) 13
Malfunction 13
Improper or incorrect procedure or method 5
No Known Device Problem 5
Loose 5
Device remains implanted 4
Failure to separate 4
Malposition of device 3
Disengaged 3
Disassembly 2
Size incorrect for patient 2
Migration of device or device component 2
Fitting problem 2
Defective component 1
Cable, defective 1
Foreign material present in device 1
Material integrity issue 1
Unintended movement 1
Device abrasion from instrument or another object 1
Metal shedding debris 1
Replace 1
Failure to Adhere or Bond 1
Component(s), broken 1
Crack 1
Displacement 1
Explanted 1
Total Device Problems 342

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 1 1 0 0 0 0 0 1 1
Class III 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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