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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 1325
Fracture 165
No code available 70
Crack 61
Material fragmentation 22
Disassembly 21
Difficult to remove 19
Component missing 18
Mechanical jam 15
Malfunction 13
Failure to disconnect 13
Device operates differently than expected 12
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Mechanical issue 11
Sticking 9
No Information 9
Loose or intermittent connection 8
Fitting problem 7
Bent 7
Unknown (for use when the device problem is not known) 6
Connection issue 6
Material deformation 6
Naturally worn 6
Detachment of device or device component 5
Failure to Adhere or Bond 5
Detachment of device component 4
Component(s), worn 4
Device remains implanted 3
Tip breakage 3
Device-device incompatibility 3
Device or device fragments location unknown 3
Dislodged or dislocated 2
Scratched material 2
Unintended movement 2
Defective item 2
Device Issue 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
Fluid leak 1
Haptic(s), detached 1
Imprecision 1
Device Cleaning Issue 1
Dull 1
Device damaged prior to use 1
Device inoperable 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Failure to separate 1
Failure to align 1
Dent in material 1
No Known Device Problem 1
Material integrity issue 1
Total Device Problems 1917

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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