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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device punch, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRY
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PREMIER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 41
No code available 11
Device operates differently than expected 3
Fracture 3
Dislodged or dislocated 2
Foreign material present in device 1
No Information 1
Burn of device or device component 1
Detachment of device component 1
Contamination during use 1
Crack 1
Disassembly 1
Material fragmentation 1
Difficult to insert 1
Incorrect measurement 1
Delivered as unsterile product 1
Difficult to remove 1
Other (for use when an appropriate device code cannot be identified) 1
Device or device fragments location unknown 1
Deployment issue 1
Detachment of device or device component 1
Bent 1
Total Device Problems 77

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Sep-17-2012
2 Clorox Healthcare Holdings, LLC (dba HealthLink) II Jul-02-2013
3 DePuy Orthopaedics, Inc. II Feb-09-2016

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