| TGA Action ID |
RC-2026-RN-00569-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SACRO Sacrocolpopexy Tips
Product Code: SACRO-1C
Lot Numbers: 550020374, 550015857
Product Code: SACRO-1
Lot Number: 550020368 |
| ARTG Number |
176064 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Certain LOTs were assembled with an internal hub in the incorrect orientation. The inverted assembly prevents the tip from being attached to the compatible RUMI system or Advincula Arch handle.
If the SACRO Sacrocolpopexy Tip cannot be properly attached to the Snap Drum feature on the compatible RUMI System or Advincula Arch Handle, the user may need to select a replacement SACRO Sacrocolpopexy Tip or an appropriate alternative instrument/approach. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine any affected product to prevent further use.
- Return affected stock. |
| Action Commencement Date |
29/07/2026 |
| Responsible Entity |
|
| Contact Information |
02 9869 2868 - Endotherapeutics Customer Service |