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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 3
Fracture 2
Device, or device fragments remain in patient 2
Tip breakage 2
Malfunction 2
Implant, removal of 1
Loose 1
Total Device Problems 13

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Jan-16-2013
2 Zimmer Inc. II Mar-04-2009

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