• 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 device, prosthesis alignment
Regulation Description Prosthetic and orthotic accessory.
Product CodeIQO
Regulation Number 890.3025
Device Class 1

Device Problems
Fracture 4
Detachment of device component 3
Break 2
Dislodged or dislocated 2
Component falling 1
Foreign material 1
Device, or device fragments remain in patient 1
Other (for use when an appropriate device code cannot be identified) 1
Device, removal of (non-implant) 1
Total Device Problems 16

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Aug-17-2012
2 Stryker Howmedica Osteonics Corp. II Aug-26-2009

-
-