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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00853-3
Product Name/Description ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)

All lot numbers

ARTG Number : 188736
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/08/2012
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue There have been isolated reports of postoperative fever and inflammatory reactions (in the absence of bacterial infection) with use of Actifuse ABX in paediatric patients undergoing surgical removal of large juvenile bone cysts. The reported side effects had no negative impact on therapeutic outcome or function of the ACTIFUSE product. The Instructions for Use will be updated to include the reported problems as precautionary statement
Recall Action Recall for Product Correction
Recall Action Instructions Updated Instructions for Use (IFU) is being provided to all users of the affected devices.
Contact Information 02 8845 1681 - Baxter Quality Assurance