Medical device licence · 66526 · Class 2
REVITAN HIP INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 22, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66526
- Licence holder
- Zimmer Switzerland Manufacturing GmbhWinterthur, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 22, 2004
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REVITAN MODULAR GUIDE DISTAL STRAIGHT
- REVITAN MODULAR RASP, DISTAL CURVED
- REVITAN MODULAR RASP, PROXIMAL, CONICAL
- REVITAN MODULAR RASP, PROXIMAL, CYLINDRICAL
- REVITAN MODULAR THREE-FLUTED DRILL BIT
- REVITAN REAMER, CONICAL
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 “revitan”. A notice may cover another product or only some lots: read it to see what it covers.
- Revitan Modular Rasp Distal Curved and Revitan Rasp Distal Curved (2017-12-27)January 29, 2018 · Medical devices · Medical devices · Type II
- Revitan Modular Revision Hip Systems (2017-01-20)February 1, 2017 · Medical devices · Medical devices · Type II
- Revitan Proximal Stems (2016-03-17)March 29, 2016 · 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.