ApprovalTrail

Medical device licence · 62436 · Class 3

DURACON TOTAL KNEE SYSTEM

No longer licensed: merged into another licence

Licence status Merged into another licence; first licensed May 9, 2003; ended January 25, 2005. It is in Health Canada’s archive of licences no longer in force.
Licence number
62436
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 9, 2003
Ended
January 25, 2005
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • DURACON TOTAL KNEE SYSTEM - ANGLED TIBIAL WEDGE AUGMENTS
  • DURACON TOTAL KNEE SYSTEM - FLAT TIBIAL WEDGE AUGMENTS
  • DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIABIAL AUGMENTS
  • DURACON TOTAL KNEE SYSTEM - MODULAR FEMORAL COMPONENT
  • DURACON TOTAL KNEE SYSTEM - MONOLITHIC (PS) FEMORAL COMPONENTS, NON-BEADED
  • DURACON TOTAL KNEE SYSTEM - STABILIZER BOX
  • DURACON TOTAL KNEE SYSTEM - STABILIZER FEMORAL COMPONENTS, NON-BEADED
  • DURACON TOTAL KNEE SYSTEM - STEMMED STABILIZING FEMORAL COMPONENTS
  • DURACON TOTAL KNEE SYSTEM - UNIVERSAL BASEPLATES, NON-BEADED
  • DURACON TOTAL KNEE SYSTEM -UNIVERSAL BASEPLATES, BEADED

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “duracon”. A notice may cover another product or only some lots: read it to see what it covers.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.