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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
Fracture 120
Break 41
Malfunction 13
Device, removal of (non-implant) 11
Device, or device fragments remain in patient 11
Unknown (for use when the device problem is not known) 6
Sticking 4
Component(s), worn 4
Material fragmentation 3
Tip breakage 3
Failure to Adhere or Bond 3
Device remains implanted 3
Component missing 3
Device or device fragments location unknown 2
Disassembly 2
Disengaged 2
Flaked 2
Detachment of device component 2
Crack 1
Haptic(s), detached 1
Mechanical issue 1
Delivered as unsterile product 1
Difficult to remove 1
Total Device Problems 240

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 3 1 0 0 1 0
Class III 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-10-2007
3 Stryker Howmedica Osteonics Corp. II Aug-27-2009
4 Stryker Howmedica Osteonics Corp. II Oct-20-2008
5 Stryker Howmedica Osteonics Corp. II May-14-2008
6 Zimmer Inc. II Sep-20-2008

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