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