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
• 
  Affected products

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