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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, bone, non-spinal, metallic
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeNDJ
Regulation Number 888.3040
Device Class 2

Device Problems
No Information 147
Implant, removal of 118
Loss of osseointegration 105
Loose or intermittent connection 66
Loose 59
Loss of or failure to bond 37
Unknown (for use when the device problem is not known) 36
No code available 28
Malposition of device 28
Dislodged or dislocated 23
Metal shedding debris 19
Break 14
Other (for use when an appropriate device code cannot be identified) 13
Noise, Audible 13
Migration of device or device component 10
Dislocated 6
Disassembly 5
Fracture 5
Component(s), broken 2
Corrosion 2
Size incorrect for patient 2
Slippage of device or device component 1
Nonstandard device or device component 1
Displacement 1
Total Device Problems 741

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. III Jan-23-2012
2 Zimmer, Inc. II May-29-2015
3 Zimmer, Inc. II Feb-20-2014

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