| TGA Action ID |
RC-2025-RN-00417-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HELIX GM IMPLANT 4.0 X 11.5 ACQUA
Product code: 140.984
Lot number: JPZ21
Manufacturing date: 22 January 2022
Expiry date: 21 January 2026 |
| ARTG Number |
329014 |
| Unique Device Identifier (UDI) |
7899878025290 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer's investigation of a customer complaint identified a possible mix-up of Helix GM Implants with heights of 11.5 mm and 13 mm. It is possible that a package labelled as 140.984 HELIX GM IMPLANT 4.0X11.5 ACQUA lot JPZ21 contains a 13mm HELIX GM IMPLANT instead of a 11.5mm implant.
The detectability of the differences in height is considered to be low. In borderline cases, where the bone quality is low and/or the bone ridge has a maximum indication of implant height without compromising noble anatomical structures, proceeding with the surgical installation of a 13 mm long implant instead of an 11.5mm long implant could cause harm to the patient such as injury to nerve structures, communication with bone cavities and/or fracture of the alveolar bone plate. |
| Instructions for Customers/Users |
Customers are to:
- Inspect and quarantine affected stock on hand to prevent further use.
- Return the completed customer response form and the affected stock to the sponsor.
- If replacement stock is required, contact the customer service team on 1800 660 330 or Customerservice.au@straumann.com
Customers are to be aware that no additional actions are necessary with successfully inserted implants. If the product has been implanted, it is not necessary to remove the implant and additional patient follow-up is not required.
All dental implants should be monitored at regular intervals in the dental practice in accordance with state-of-the-art dental implantology practices as per Instruction for Use, GM Helix Implant 330.324.09.
This action has been closed out on 13/02/2026. |
| Action Commencement Date |
30/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 660 330 - Straumann Customer Service |