Medical device licence · 297 · Class 3
REFLECTION ACETABULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 297
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 18, 1998
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PERIPHERAL SCREW DRILL
- REF. ACETABULAR SYS REF. 10 MRAD CROSS-LINKED POLYETHYLENE ACETAB. LINERS
- REFLECTION ACETABULAR LINER TRIAL
- REFLECTION ACETABULAR SHELL TRIAL
- REFLECTION ACETABULAR SYSTEM - CONSTRAINED LINER
- REFLECTION ACETABULAR SYSTEM - CONSTRAINED LINER ADAPTER
- REFLECTION ACETABULAR SYSTEM - HA COATED 3-HOLE SHELL
- REFLECTION ACETABULAR SYSTEM - INTERFIT THREADED HOLE COVER
- REFLECTION ACETABULAR SYSTEM - LATERALIZED ACETABULAR LINER TRIAL
- REFLECTION ACETABULAR SYSTEM - LINER TRIAL NO OVERHANG
- REFLECTION ACETABULAR SYSTEM - LOCKING HEAD PEG
- REFLECTION ACETABULAR SYSTEM - MULTI-HOLE SHELL
- REFLECTION ACETABULAR SYSTEM - NO HOLE SHELL
- REFLECTION ACETABULAR SYSTEM - PEG REMOVAL PIN
- REFLECTION ACETABULAR SYSTEM - SCREW HOLE COVER
- REFLECTION ALL-POLY XLPE CUP
- REFLECTION ANTEVERTED ACETABULAR LINER TRIAL
- REFLECTION SPHERICAL HEAD CANCELLOUS SCREW
- REFLECTION THREADED CENTRAL HOLE COVER
- REFLECTION XLPE MICROSTABLE ACETABULAR LINER
- REFLECTON ACETABULAR SYSTEM - 3 HOLE SHELL
- UNIVERSAL ACETABULAR CANCELLOUS SCREWS
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 “reflection”. A notice may cover another product or only some lots: read it to see what it covers.
- Reflection Dead Blow MalletDecember 16, 2016 · Medical devices · Type II
- REFLECTION ACETABULAR SYSTEM - SCREW (2016-07-06)July 22, 2016 · Medical devices · Medical devices · Type II
- REFLECTION ACETABULAR SYSTEM - SCREW (2015-11-11)November 11, 2015 · Medical devices · Type III
- REFLECTION 3 Acetabular System-Constrained Acetabular Liner (2015-05-08)June 3, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.