Medical device licence · 104445 · Class 3
PROFEMUR TL2 HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104445
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 19, 2020
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROFEMUR TL2 BROACH
- PROFEMUR TL2 STEM (HIGH OFFSET)
- PROFEMUR TL2 STEM (STANDARD NECK)
- PROFEMUR TL2 STEM (ULTRA HIGH OFFSET)
- PROFEMUR TL2 TRIAL NECK HIGH OFFSET GROUP
- PROFEMUR TL2 TRIAL NECK STANDARD GROUP
- PROFEMUR TL2 TRIAL NECK ULTRA HIGH OFFSET GROUP
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
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.