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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, non-powered
Regulation Description Nonpowered neurosurgical instrument.
Product CodeHAO
Regulation Number 882.4535
Device Class 1


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Break 39
Degraded 24
Material integrity issue 3
Tip breakage 2
Device operates differently than expected 2
Material fragmentation 2
Device, or device fragments remain in patient 2
Difficult to remove 1
Imprecision 1
Material discolored 1
Entrapment of device or device component 1
Fracture 1
Dislodged or dislocated 1
Connection issue 1
No Information 1
Failure to Adhere or Bond 1
Total Device Problems 83

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 0 0 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 Integra LifeSciences Corp I Sep-22-2010
2 Zimmer Inc. II Jun-29-2011

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