Medical device licence · 83299 · Class 2
VERSYS HIP SYSTEM PROVISIONALS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83299
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 7, 2010
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VERSYS HIP SYSTEM CEMENTED REV./CALCAR PROVISIONAL CONE COMPONENT-COLLARED
- VERSYS HIP SYSTEM CEMENTED REVISION/CALCAR FEMORAL STEM PROVISIONAL
- VERSYS HIP SYSTEM CEMENTED REVISION/CALCAR PROVISIONAL BLOCK
- VERSYS HIP SYSTEM CEMENTED REVISION/CALCAR PROVISIONAL DISTAL CENTRALIZER
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARED
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARED EXTENDED OFFSET
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARED EXTRA EXTENDED OFFSET
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARED REVISION OFFSET
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARLESS
- VERSYS HIP SYSTEM PROVISIONAL CONE COMPONENT COLLARLESS EXTENDED OFFSET
- VERSYS HIP SYSTEM PROVISIONAL FEMORAL STEM POROUS FULLCOAT BOWED
- VERSYS HIP SYSTEM PROVISIONAL FEMORAL STEM POROUS FULLCOAT STRAIGHT
- VERSYS HIP SYSTEM PROVISIONAL RASP TIP POR
- VERSYS HIP SYSTEM PROVISIONAL RASP TIP POR REV
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.