Medical device licence · 85788 · Class 3
PROFEMUR GLADIATOR HIP STEM - TITANIUM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 13, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85788
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 13, 2011
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROFEMUR GLADIATOR BROACH
- PROFEMUR GLADIATOR PLASMA TI STEM
- PROFEMUR GLADIATOR STEM HA COATED
- PROFEMUR GLADIATOR STEM HA COATED COLLARLESS
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.