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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neurosurgical paddie
Regulation Description Neurosurgical paddie.
Product CodeHBA
Regulation Number 882.4700
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 61
Component missing 12
Incorrect device or component shipped 12
Foreign material present in device 8
Break 5
Material frayed 3
No code available 3
Tears, rips, holes in device, device material 2
Material discolored 2
Device Issue 2
Detachment of device or device component 2
Device misassembled during manufacturing or shipping 1
No Known Device Problem 1
Use of Device Issue 1
Defective component 1
Performance 1
Detachment of device component 1
Total Device Problems 118

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

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Codman & Shurtleff, Inc. II Oct-20-2010

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