Medical device licence · 34243 · Class 3
COLLARLESS POLISHED CEMENTED STEM (CPCS) HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 23, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 34243
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 23, 2001
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLLARLESS POLISHED CEMENTED STEM (CPCS) HIP SYSTEM - BROACH
- COLLARLESS POLISHED CEMENTED STEM (CPCS) HIP SYSTEM - STARTER BROACH
- COLLARLESS POLISHED CEMENTED STEM (CPCS) HIP SYSTEM - TRIAL NECK
- CPCS TOTAL HIP SYSTEM - CENTRALIZER
- CPCS TOTAL HIP SYSTEM - COCR PRIMARY
- CPCS TOTAL HIP SYSTEM - SS FEMORAL HEAD
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 “collarless”. A notice may cover another product or only some lots: read it to see what it covers.
- Echo Bi-Metric Collarless Porous Stem, Size 7 (2017-12-28)April 24, 2018 · 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.