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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 56
Unknown (for use when the device problem is not known) 37
Difficult to insert 35
Mechanical issue 28
No code available 28
Break 21
Fracture 15
Malposition of device 15
Other (for use when an appropriate device code cannot be identified) 13
Malfunction 13
No Known Device Problem 9
Failure to separate 5
Component missing 5
Migration of device or device component 5
Improper or incorrect procedure or method 5
Loose 5
Corrosion 5
Device remains implanted 4
Disengaged 3
Positioning Issue 3
Unintended movement 2
Material integrity issue 2
Material fragmentation 2
Disassembly 2
Fitting problem 2
Size incorrect for patient 2
Out-of-box failure 2
Defective component 2
Cable, defective 1
Device contamination with blood or blood product 1
Device markings issue 1
Device or device component damaged by another device 1
Foreign material present in device 1
Incorrect device or component shipped 1
Metal shedding debris 1
Replace 1
Incorrect or inadequate result 1
Unsealed device packaging 1
Material discolored 1
Crack 1
Component(s), broken 1
Detachment of device component 1
Failure to Adhere or Bond 1
Bent 1
Displacement 1
Explanted 1
Device abrasion from instrument or another object 1
Mechanical jam 1
Packaging issue 1
Total Device Problems 429

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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