• 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 probe
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXB
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 44
Fracture 8
Device, or device fragments remain in patient 2
Tip breakage 2
Naturally worn 2
Output below specifications 1
Bent 1
Metal shedding debris 1
Improper or incorrect procedure or method 1
Defective item 1
Total Device Problems 63

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

Recalls
Manufacturer Recall Class Date Posted
1 SpineFrontier, Inc. II Jan-03-2014
2 Zimmer Trabecular Metal Technology, Inc. II Dec-23-2014

-
-