| TGA Action ID |
RC-2025-RN-00563-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Spinal Kinetics M6-C Artificial Cervical Disc Replacement Devices
Item Codes: CDM-625, CDM-635L, CDL-627, CDL-637L, CDM-725, CDM-735L, CDL-727, CDL-737L
ARTG 177101 (cancelled as of 14/05/2025) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
Previously under ARTG 177101. UDI as per table in customer letter |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
After conducting a post-market review on the Spinal Kinetics M6-C implants, the TGA have determined that there was insufficient evidence to support the use of this implant in 2-level and above non-contiguous; 3-level and above contiguous cervical disc replacements (CDR); and hybrid use (such as ACDF hybrid constructs).
The relevant changes to the IFU and PIL have been made to reflect this determination.
The intended purpose of the M6-C implant now only includes single level or 2 level contiguous CDR.
Product Alert:
Routine long term clinical and radiographic monitoring of patients implanted with the M6-C is suggested to assess any changes in implant condition or surrounding anatomy.
Product Correction:
The current Instructions for Use (IFU) and Patient Information Leaflet (PIL) for the Spinal Kinetics M6-C implants have been superseded. A new IFU/PIL contains updated intended purpose for use and contraindications. |
| Instructions for Customers/Users |
Hospitals are to:
- Provide the customer letter to all practitioners that used these devices.
- Review the alert and updated documents included in the notification;
Surgeons are to:
- Be aware that patients who are determined to have had 2-level and above non-contiguous OR 3 level and above contiguous cervical disc replacements (CDR) OR hybrid use, should have close radiographic and clinical follow up.
This action has been finalised on 9/7/2026. |
| Action Commencement Date |
30/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 168 - LifeHealthcare |