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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 757
Fracture 136
No code available 34
Crack 29
Material fragmentation 18
Disassembly 15
Mechanical jam 14
Malfunction 13
Component missing 12
Device, or device fragments remain in patient 11
Device operates differently than expected 11
Device, removal of (non-implant) 11
Difficult to remove 10
Sticking 9
Loose or intermittent connection 8
Failure to disconnect 8
Fitting problem 7
Material deformation 6
Naturally worn 6
Mechanical issue 6
No Information 6
Bent 6
Unknown (for use when the device problem is not known) 6
Failure to Adhere or Bond 5
Detachment of device or device component 4
Component(s), worn 4
Detachment of device component 4
Device remains implanted 3
Device or device fragments location unknown 3
Tip breakage 3
Corrosion 2
Dislodged or dislocated 2
Connection issue 2
Failure to align 2
Component falling 2
Scratched material 2
Flaked 2
Device Issue 2
Unintended movement 2
Disengaged 2
Dent in material 1
Device-device incompatibility 1
Failure to separate 1
Haptic(s), detached 1
Defective item 1
Slippage of device or device component 1
Delivered as unsterile product 1
No Known Device Problem 1
Metal shedding debris 1
Particulates 1
Retraction problem 1
Material integrity issue 1
Device inoperable 1
Device Cleaning Issue 1
Migration of device or device component 1
Failure to sterilize 1
Total Device Problems 1201

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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