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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wrench
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXC
Regulation Number 888.4540
Device Class 1

Device Problems
Break 40
Fracture 10
Component missing 8
No code available 8
Output issue 6
Material torqued 5
Device inoperable 5
Output above specifications 3
Material fragmentation 3
Crack 3
Calibration issue 3
Malfunction 2
Disassembly 2
Loose or intermittent connection 2
Device, or device fragments remain in patient 2
Bent 2
Tip breakage 2
Sticking 1
Fitting problem 1
Implant, removal of 1
Loose 1
Material discolored 1
Failure to disconnect 1
Component or accessory incompatibility 1
Mechanics altered 1
Output below specifications 1
Positioning Issue 1
Misassembled by Users 1
Total Device Problems 117

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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Aug-03-2015
2 Biomet Spine, LLC II Apr-20-2015
3 Bradshaw Medical Inc. II May-10-2016
4 DePuy Spine, Inc. II Jan-16-2013
5 Orthofix, Inc II Feb-11-2016
6 Zimmer Inc. II Mar-04-2009

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