Medical device licence · 10622 · Class 3
AEQUALIS SHOULDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 1, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10622
- Licence holder
- Tornier S.A.S.Montbonnot-Saint-Martin, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 1, 1999
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AEQUALIS - FRACTURE - TRIAL STEM FOR FRACTURE
- AEQUALIS GLENOID - KEELED GLENOID TRIAL
- AEQUALIS INSTRUMENT - HUMERAL HEAD TRIAL
- AEQUALIS TOTAL SHOULDER SYSTEM - AEQUALIS GLENOID USA
- AEQUALIS TOTAL SHOULDER SYSTEM - AEQUALIS OPEN STEM FOR FRACTURE
- AEQUALIS TOTAL SHOULDER SYSTEM - FRACTURE STEM US WITH HA
- AEQUALIS TOTAL SHOULDER SYSTEM - HUMERAL HEAD
- AEQUALIS TOTAL SHOULDER SYSTEM - HUMERAL STEM
- AEQUALIS TOTAL SHOULDER SYSTEM - PRESS-FIT 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 “aequalis”. A notice may cover another product or only some lots: read it to see what it covers.
- Aequalis® Flex Revive® Assembly ScrewJune 21, 2023 · Orthopaedics · Labelling and packaging · Type II
- Aequalis Ascend Flex - Humeral Stems (2019-11-11)November 29, 2019 · Medical devices · Medical devices · Type III
- AEQUALIS Humeral Nail Drill Bit (2018-05-11)July 13, 2018 · Medical devices · Medical devices · Type II
- Aequalis Humeral Nail Targeting Jig (2015-07-21)August 11, 2015 · Medical devices · Health products · Type II
- Aequalis - Humeral Implant Broach (2014-12-08)December 23, 2014 · Medical devices · Medical devices · Type II
- Tornier Aequalis Reversed Impactors (2013-08-13)December 17, 2013 · 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.