Optipac 60 Refobacin Bone Cement R

Recall Summary Optipac 60 Refobacin Bone Cement R, a bone cement used in orthopedic surgery, is recalled across Canada due to a classification issue. The product was classified and distributed without proper authorization or verification of its safety and effectiveness standards. This recall affects healthcare facilities and surgical centers that received this product for use in bone-related surgical procedures.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-08-23

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b651040f-6e6f-4a1a-9028-e65f55c2d129