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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

Device Problems
Fracture 8
Break 7
Unknown (for use when the device problem is not known) 3
Tip breakage 2
Malfunction 2
No Known Device Problem 1
No Information 1
Other (for use when an appropriate device code cannot be identified) 1
Device Issue 1
Corrosion 1
Product quality issue 1
Device, or device fragments remain in patient 1
Total Device Problems 29

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 1 2 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-05-2011
2 Stryker Howmedica Osteonics Corp. II Sep-19-2008
3 Zimmer Inc. II Jul-07-2009
4 Zimmer Inc. II May-12-2009

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