| TGA Action ID |
RC-2025-RN-00762-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Precision AI Orthopaedic implantation application software
Version: V2025.1.2 |
| ARTG Number |
355602 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During the landmarking stage in software version V2025.1, the system failed to execute the shoulder feature extraction calculation when landmarks were adjusted. This resulted in a misalignment between the bone model used for surgical planning and the bone model used for patient-specific instrument (PSI) generation. Consequently, the PSI was produced against a different frame of reference than the approved surgical plan, leading to nonconforming guides.
The potential harm to the patient is surgical intervention such as additional bone resection and/or additional implant spacer utilisation may be required. One adverse event was reported. |
| Instructions for Customers/Users |
Customers are to:
- Avoid planning surgeries on the Precision AI platform, or using any Precision AI-generated guides until further notice as they are not suitable for clinical use.
- Contact Precision AI with any questions or concerns.
A software product correction is underway and customers will be contacted when available.
This action has been closed out on 03/12/2025 |
| Action Commencement Date |
9/09/2025 |
| Responsible Entity |
|
| Contact Information |
1300 667 730 - Enovis Australia |