Optipac Refobacin Bone Cement R
- Starting date:
- November 21, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61182
Reason
Biomet Orthopaedics Switzerland GmbH is conducting a medical device field safety corrective action (removal) of Optipac Bone Cement involving all sizes manufactured since January 2014. During internal investigation, it was identified that Biomet Orthopaedics cannot guarantee that the sterilization process for the Optipac is fully compliant.
Affected products
Optipac Refobacin Bone Cement R
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4710500394
4710500394-1
4711500396
4711500396-1
4712500398
4712500398-1
Companies
- Manufacturer
-
Biomet Orthopaedics Switzerland GmbH
Riedstrasse 6
Dietikon
8953
SWITZERLAND