| TGA Action ID |
RC-2026-RN-00452-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Phantom Hindfoot TCC/TC Ball Tipped Guide Rod 3.0 x 800mm Sterile
Part Number: P31-955-1800-S
Lot Numbers: 501167202225, 501167302225, 501209514725, 501259627925, 501275832225 |
| ARTG Number |
289488 |
| Unique Device Identifier (UDI) |
(01)00889795061577(17)300122(10)501167202225, (01)00889795061577(17)300122(10)501167302225, (01)00889795061577(17)300527(10)501209514725, (01)00889795061577(17)301006(10)501259627925, (01)00889795061577(17)301118(10)501275832225 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Two (2) complaints were received, involving four (4) units, regarding breaches of the sterile barrier on the pouches used to package the guide rod.
If the user does not identify the sterile barrier breach prior to surgery, this can cause the non-sterile device to be used and lead to infection. This infection can lead to further surgical intervention. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine affected batches on hand to prevent further use.
- Return affected stock.
- Contact the manufacturer to arrange replacement stock or discuss alternative products. |
| Action Commencement Date |
29/06/2026 |
| Responsible Entity |
|
| Contact Information |
(08) 7084 5277 - Actis Medical |