| TGA Action ID |
RC-2025-RN-00783-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Dreamline Saddleback Trunk Lateral Brackets
Product Numbers: DLSA, DLSALRP, DLSALRK, DLSAC, DLSALR, DLSALRPK, DLSAP, DLSACP
UDI: 94200653SUPPORTSH8 |
| ARTG Number |
461989 |
| Unique Device Identifier (UDI) |
94200653SUPPORTSH8 |
| Action Type |
Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
A problem has been identified with the release lever affecting some Dreamline Saddleback thoracic swing-away lateral brackets from the initial production batch. In certain cases, the release lever has disengaged under force, which could affect the lateral stability of the user on that side. |
| Instructions for Customers/Users |
Customers should
· Identify the “occupants” in the field with the affected product and arrange with them a suitable time to make the replacement.
· Identify any demo units or in house items and set these aside for immediate collection so they can be corrected and returned immediately. Rolapal will arrange despatch for non-inhouse or demo laterals.
· Once replaced in the field, please set aside all (non-inhouse) affected lateral brackets identified in the listed PO numbers for collection by Rolapal.
· Rolapal Ltd will arrange collection of the affected brackets directly from you once all have been confirmed as replaced in the field.
This action has been finalised on 06/01/2026. |
| Action Commencement Date |
23/09/2025 |
| Responsible Entity |
|
| Contact Information |
1300 251 545 - Rolapal Customer Support |