Medical device licence · 12068 · Class 3
EXETER TOTAL HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 17, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12068
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 17, 1999
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXETER FEMORAL NECK TRIAL
- EXETER MOD RASP
- EXETER MODULAR RASP
- EXETER MODULAR RASP A/P
- EXETER PLUG INTRODUCER
- EXETER RASP
- EXETER TAPERED PIN REAMER
- EXETER TOTAL HIP SYSTEM - ORTHINOX V40 FEMORAL HEADS
- EXETER TOTAL HIP SYSTEM - STEM & HEAD
- EXETER TOTAL HIP SYSTEM - V40 FEMORAL STEMS
- EXETER TRIAL HEAD STANDARD NECK
- EXETER V 40 CEMENTED HIP STEM
- EXETER V40 CEMENTED HIP LONG TAPERED STEM
- EXETER V40 TRIAL STEM
- SPECIALTY EXETER FLEXIBLE TRIAL PLUG
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 “exeter”. A notice may cover another product or only some lots: read it to see what it covers.
- Exeter Stem (Size 0)May 2, 2017 · Medical devices · Type II
- EXETER RASP HANDLE (2016-06-22)July 19, 2016 · Medical devices · Medical devices · Type II
- EXETER TAPERED PIN REAMER-LARGE (2015-09-24)October 14, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.