Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device joint, knee, external limb component
Regulation Description External limb prosthetic component.
Product CodeISY
Regulation Number 890.3420
Device Class 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 1 0 1 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bock,Otto,Orthopedic Ind,Inc II Dec-16-2009
2 Medi Manufacturing Inc II Apr-24-2007
3 Ossur II Jul-12-2007
4 Ossur Engineering, Inc II Mar-25-2011
5 Ossur H / F II Feb-06-2012

-
-