Medical device licence · 67735 · Class 3
RENASYS KNEE SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 14, 2005; ended November 5, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 67735
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 14, 2005
- Ended
- November 5, 2018
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RENASYS HIGH PERFORMANCE KNEE - BICONVEX REAMER
- RENASYS HIGH PERFORMANCE KNEE - BICONVEX SECONDARY REAMER
- RENASYS HIGH PERFORMANCE KNEE - FEMORAL PRIMARY OXINIUM CEMENTED PS
- RENASYS HIGH PERFORMANCE KNEE - FIXATION PIN
- RENASYS HIGH PERFORMANCE KNEE - PATELLA BICONVEX
- RENASYS HIGH PERFORMANCE KNEE - PATELLA RESURFACING ROUND
- RENASYS HIGH PERFORMANCE KNEE - PS REAMER
- RENASYS HIGH PERFORMANCE KNEE - RESURFACING REAMER
- RENASYS HIGH PERFORMANCE KNEE - TIBIAL INSERT PRIMARY PS
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 “renasys”. A notice may cover another product or only some lots: read it to see what it covers.
- RENASYS™ EDGE Negative Pressure Wound TherapyOctober 23, 2024 · General hospital and personal use · Performance · Type II
- Renasys Edge Canister With SolidifierMarch 28, 2024 · General hospital and personal use · Performance · Type II
- RENASYS GAUZE DRESSING, FISTULA KIT and TRANSPARENT FILM (2016-07-22)August 5, 2016 · Medical devices · Medical devices · Type II
- RENASYS GO NEGATIVE PRESSURE WOUND THERAPY SYSTEM - POWER SUPPLY (2016-02-29)March 10, 2016 · Medical devices · Medical devices · Type II
- RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY (2015-02-02)April 2, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.