• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device extractor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWB
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 74
Fracture 36
Material fragmentation 11
Device operates differently than expected 8
No code available 7
Malfunction 5
Unknown (for use when the device problem is not known) 4
Material deformation 4
Mechanical jam 3
Fitting problem 3
Disassembly 2
Bent 1
Component(s), broken 1
Dull 1
Failure to align 1
Detachment of device or device component 1
Loose or intermittent connection 1
Peeled 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Tip breakage 1
Metal shedding debris 1
Interlock(s), failure of 1
No Known Device Problem 1
Material integrity issue 1
Total Device Problems 171

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 2 0 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 Dec-28-2010
2 Stryker Howmedica Osteonics Corp. II Apr-27-2010

-
-