• 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 hammer, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeFZY
Regulation Number 878.4800
Device Class 1

Device Problems
Break 58
Foreign material present in device 31
Residue after decontamination 26
Leak 15
No code available 10
Fracture 5
Connection issue 4
Disassembly 3
Bent 3
Crack 2
Metal shedding debris 2
Component missing 2
Mechanical jam 2
No Information 1
Dull 1
Dent in material 1
Detachment of device or device component 1
Material deformation 1
Material Distortion 1
Material disintegration 1
Failure to Adhere or Bond 1
Component falling 1
Total Device Problems 172

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 EBI, L.P. II Sep-16-2008
2 SpineFrontier, Inc. II Aug-01-2013

-
-