Medical device licence · 80485 · Class 3
OPTIPAC REFOBACIN BONE CEMENT R
No longer licensed: cancelled
Licence status Cancelled; first licensed August 18, 2009; ended January 4, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80485
- Licence holder
- Biomet Orthopaedics Switzerland GmbhDietikon, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- August 18, 2009
- Ended
- January 4, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTIPAC REFOBACIN BONE CEMENT R
- OPTIPAC REFOBACIN PLUS BONE CEMENT
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 “optipac”. A notice may cover another product or only some lots: read it to see what it covers.
- Optipac Refobacin Bone Cement R (2019-12-20)January 10, 2020 · Medical devices · Medical devices · Type III
- Optipac Refobacin Bone Cement RNovember 21, 2016 · Medical devices · Type I
- OPTIPAC 60 Refobacin Bone Cement RAugust 23, 2016 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.