| TGA Action ID |
RC-2025-RN-00382-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
da Vinci X and Xi Tenaculum Forceps and Small Graptor
X Tenaculum Forceps
Part Number: 470207
Version Number: Version 12 and below
Xi 8mm Small Graptor
Part Number: 470318
Version Number: Version 14 and below
All lot numbers
ARTG's: 146826 & 319418 |
| ARTG Number |
146826, 319418 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for pitch cable failures associated with the Tenaculum Forceps and Small Graptor. These failures may result in a cable fragment becoming dislodged from the instrument during use. The cable can fail partially (i.e. frayed) or completely (i.e. broken).
This action follows on from two previously communicated Urgent Product Alerts: RC-2024-RN-00858-1 & RC-2025-RN-00017-1. |
| Instructions for Customers/Users |
The updated versions of the Tenaculum Forceps and Small Graptor instruments are now available, and all previous versions are the subject of this recall.
Customers should review their stock for the affected Products and then return them to Device Technologies, ensuring they sign the outer packaging clearly with the word “RECALL 623-INS0325”.
If customers identify affected stock in the response form Device Technologies will contact them for collection.
This action has been finalised on 9/7/2025. |
| Action Commencement Date |
9/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 999 323 - Device Technologies Australia |