Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01539-1
Product Name/Description	Optipac Bone Cement Optipac 40 Refobacin Plus Bone Cement Optipac 60 Refobacin Plus Bone Cement Optipac 80 Refobacin Plus Bone Cement Optipac-S 40 Refobacin Plus Bone Cement Optipac-S 60 Refobacin Plus Bone Cement Optipac-S 80 Refobacin Plus Bone Cement All sizes manufactured since January 2014 Multiple Material and Batch Numbers ARTG Number: 168753
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/11/2016
Responsible Entity	Zimmer Biomet Pty Ltd
Reason/Issue	Through an internal investigation Biomet Orthopaedics has identified that the sterilisation process for Optipac Bone Cement cannot be guaranteed to be fully compliant. The most probable potential risks related to this sterilisation issue include: - inflammation - pain - early infection - potential swelling around the joint Biomet Orthopaedics conducted a review of complaints for the Optipac and the reported rate for infections was 0.0004 %.
Recall Action	Recall
Recall Action Instructions	Zimmer Biomet is advising customers to immediately locate and remove affected devices, and then return these devices to Zimmer Biomet who will issue credit for returned stock. Zimmer is advising that, based on the current information, there does not appear to be a need for additional patient follow-up beyond the standard patient follow-up. This action has been closed-out on 25/05/2017.
Contact Information	02 9483 5426 - Zimmer Biomet