| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00652-1 |
| Product Name/Description |
Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone)
Catalogue number: 20900501
Lot numbers: A1203024, A1205018, A1206005, A1109035
ARTG Number: 140434 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
When removing the Aliquot catheter from the needle during a vertebroplasty procedure, there have been reported cases of the catheter breaking. This has been attributed to bending the catheter during its retraction from the needle. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is providing end users with additional information and warnings to reduce the chance of the catheter breaking due to bending during retraction. The device instructions for use will be updated to reflect this information. |
| Contact Information |
02 9467 1214 - Stryker Regulatory Affairs/Quality Assurance Coordinator |