| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00823-1 |
| Product Name/Description |
Xenform Soft Tissue Repair Matrix 8cm x 12cm
Material Number: M0068302470
Batch Number: 1602010
Expiry Date: 30 November 2018
Supplied through the Special Access Scheme (SAS)
ARTG Number: 174878 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Xenform Soft Tissue Repair Matrix is currently supplied to customers who have TGA (Therapeutic Goods Administration) approval through the Special Access Scheme (SAS). On Wednesday 15th June 2016, Boston Scientific (“BSC”) identified that units of Xenform Soft Tissue Repair Matrix were shipped from the Australian BSC distribution centre to some customers who did not have the appropriate SAS approval in place. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising users to quarantine affected stock for return. A credit note will be issued for all returned product.
This action has been closed on the 14/09/2018 |
| Contact Information |
02 8063 8144 - Boston Scientific |