Medical device licence · 16615 · Class 3
VERSYS CALCICOAT HIP STEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 8, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 16615
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- February 8, 2000
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- POROUS FEMORAL STEM COLLARED HA/TCP COATING
- POROUS TAPER FEMORAL STEM HA/TCP COATING
- VERSYS FIBER METAL MIDCOAT
- VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER FEMORAL STEM COLLARED
- VERSYS FIBER METAL TAPER
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 “versys”. A notice may cover another product or only some lots: read it to see what it covers.
- VerSys Beaded Hip Stem Femoral Stem Beaded Fullcoat Collared 12/14 Neck Taper and Zimmer Segmental System Distal Femoral Component (2017-08-11)September 5, 2017 · Medical devices · Medical devices · Type II
- Versys Beaded Fullcoat Stem - Standard,Offset and Stem-Offset (LM) (2014-06-03)June 19, 2014 · Medical devices · Medical devices · Type II
- Versys Hip Cemented Revision / Calcar (2013-09-24)October 28, 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.