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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device passer, wire, orthopedic
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXI
Regulation Number 888.4540
Device Class 1

Device Problems
Break 11
Device, or device fragments remain in patient 7
Material fragmentation 3
Device operates differently than expected 2
Material deformation 1
Delivered as unsterile product 1
Tip breakage 1
Use of Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 28

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 0 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Extremity Medical LLC II Mar-15-2013
2 Interventional Spine Inc II Jul-01-2011

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