| TGA Action ID |
RC-2026-RN-00477-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mariner Polyaxial Head components used within the Mariner Pedicle Screw System
Part Number: SEA-41-3010
Catalogue Number: 41-3010
Lot Number: AW199684G |
| ARTG Number |
275794 |
| Unique Device Identifier (UDI) |
10889981155117 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Seaspine has identified a dimensional nonconformance involving the minor thread feature of a polyaxial head component. This deviation, if present in the polyaxial head component, may result in reduced mechanical engagement between the polyaxial head and the mating screw shank.
Seaspine has received two (2) complaints in which the polyaxial head disengaged (“popping off”) during a procedure. In both cases no injuries, adverse clinical outcomes, or postoperative failures were reported. |
| Instructions for Customers/Users |
For Devices Already Implanted:
At present, the manufacturer does not recommend removal or revision of implanted devices that contain a component from the recalled lot. Surgeons should continue standard clinical follow-up and monitor for any potential adverse events.
Customers are to:
1. Locate all affected items onsite, mark the outer packaging with the word ‘RECALL’ and isolate them from use.
3. Complete and return the attached Customer Response Form.
4. Device Technologies will contact affected customers to arrange collection.
5. Include any implantation dates and quantities in the customer response form, if applicable.
This action has been closed out on 25/09/2026 |
| Action Commencement Date |
25/06/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies |