Medical device licence · 71928 · Class 3
PROFEMUR HIP SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed July 21, 2006; ended January 12, 2009. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 71928
- Licence holder
- Wright Medical Europe Manufacturing SaToulon, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 21, 2006
- Ended
- January 12, 2009
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROFEMUR HIP SYSTEM - E HIP STEM
- PROFEMUR HIP SYSTEM - EXTENSION ADAPTOR
- PROFEMUR HIP SYSTEM - NECK
- PROFEMUR HIP SYSTEM - PLASMA COATED PROXIMAL BODY
- PROFEMUR HIP SYSTEM - PROX BODY
- PROFEMUR HIP SYSTEM - STEM BOWED/FULLY COATED CYL/PLASMA SPRAYED
- PROFEMUR HIP SYSTEM - STEM BOWED/SPLINED/SLOTTED
- PROFEMUR HIP SYSTEM - STEM BOWED/TAPER
- PROFEMUR HIP SYSTEM - STEM STRAIGHT/FULLY COATED/PLASMA SPRAYED
- PROFEMUR HIP SYSTEM - STEM STRAIGHT/SPLINED/SLOTTED
- PROFEMUR HIP SYSTEM - STEM STRAIGHT/TAPER
- PROFEMUR HIP SYSTEM - TAPERED HIP STEM
- PROFEMUR HIP SYSTEM - Z PLASMA SPRAYED
- PROFEMUR HIP SYSTEM - Z REVISION STEM
- PROFEMUR HIP SYSTEM - Z STEM
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 “profemur”. A notice may cover another product or only some lots: read it to see what it covers.
- PROFEMUR Long Titanium Modular Necks (2020-07-31)August 14, 2020 · Medical devices · Medical devices · Type II
- PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck (2015-08-07)September 1, 2015 · Medical devices · Health products · Type II
- Procotyl and Profemur ProductsOctober 1, 2012 · Medical devices · Type II
- Profemur Tapered Hip System - Profemur Z Femoral Stem - Profemur TL SystemSeptember 17, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.