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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 833
Fracture 137
No code available 37
Crack 33
Material fragmentation 18
Disassembly 15
Component missing 14
Mechanical jam 14
Malfunction 13
Device operates differently than expected 12
Device, removal of (non-implant) 11
Device, or device fragments remain in patient 11
Difficult to remove 11
Sticking 9
Failure to disconnect 9
Loose or intermittent connection 8
Fitting problem 7
Unknown (for use when the device problem is not known) 6
Mechanical issue 6
Bent 6
Naturally worn 6
Material deformation 6
No Information 6
Failure to Adhere or Bond 5
Detachment of device component 4
Component(s), worn 4
Detachment of device or device component 4
Device remains implanted 3
Device or device fragments location unknown 3
Tip breakage 3
Failure to align 2
Device Issue 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
Connection issue 2
Dislodged or dislocated 2
Scratched material 2
Unintended movement 2
No Known Device Problem 1
Material integrity issue 1
Device-device incompatibility 1
Failure to separate 1
Defective item 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Device Cleaning Issue 1
Dent in material 1
Haptic(s), detached 1
Device inoperable 1
Metal shedding debris 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Total Device Problems 1290

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 0
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 Oct-30-2015
3 Encore Medical, Lp II Oct-10-2007
4 Greatbatch Medical I Nov-29-2016
5 Greatbatch Medical I Mar-06-2014
6 SpineFrontier, Inc. II Jun-05-2013
7 Stryker Howmedica Osteonics Corp. II Oct-07-2016
8 Stryker Howmedica Osteonics Corp. II Dec-27-2013
9 Stryker Howmedica Osteonics Corp. II Aug-27-2009
10 Stryker Howmedica Osteonics Corp. II Oct-20-2008
11 Stryker Howmedica Osteonics Corp. II May-14-2008
12 Zimmer Inc. II Sep-20-2008
13 Zimmer, Inc. II Nov-24-2014

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