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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device impactor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWA
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1236
Fracture 155
No code available 60
Crack 56
Material fragmentation 21
Component missing 18
Disassembly 18
Difficult to remove 17
Mechanical jam 15
Failure to disconnect 13
Malfunction 13
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Device operates differently than expected 11
No Information 9
Sticking 9
Loose or intermittent connection 8
Mechanical issue 8
Bent 7
Fitting problem 7
Unknown (for use when the device problem is not known) 6
Naturally worn 6
Material deformation 6
Detachment of device or device component 5
Failure to Adhere or Bond 5
Detachment of device component 4
Component(s), worn 4
Connection issue 4
Device-device incompatibility 3
Device or device fragments location unknown 3
Tip breakage 3
Device remains implanted 3
Device Issue 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
Defective item 2
Dislodged or dislocated 2
Scratched material 2
Unintended movement 2
Material integrity issue 1
No Known Device Problem 1
Failure to separate 1
Fluid leak 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Device Cleaning Issue 1
Failure to align 1
Dent in material 1
Device inoperable 1
Device damaged prior to use 1
Haptic(s), detached 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Total Device Problems 1789

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 1 0
Class II 1 3 1 0 0 1 2 1 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jan-30-2012
2 Encore Medical, Lp II Mar-08-2017
3 Encore Medical, Lp II Oct-30-2015
4 Encore Medical, Lp II Oct-10-2007
5 Greatbatch Medical I Nov-29-2016
6 Greatbatch Medical I Mar-06-2014
7 SpineFrontier, Inc. II Jun-05-2013
8 Stryker Howmedica Osteonics Corp. II Oct-07-2016
9 Stryker Howmedica Osteonics Corp. II Dec-27-2013
10 Stryker Howmedica Osteonics Corp. II Aug-27-2009
11 Stryker Howmedica Osteonics Corp. II Oct-20-2008
12 Stryker Howmedica Osteonics Corp. II May-14-2008
13 Zimmer Inc. II Sep-20-2008
14 Zimmer, Inc. II Nov-24-2014

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