| 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 |
|
| 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 |