| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00236-1 |
| Product Name/Description |
HACTIV HAC size 7 and 8, STEMSYS HAC Fem. stem S8 standard 135° collarless HAC and STEMSYS HAC Fem. stem S8 standard 135° collared HAC
Reference number: H49 007, H49 008, H73 008 and H73 C008
All batch numbers
ARTGs 232289, 356301, 356300 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
In order to comply with the new European regulation MDR 2017/745, Evolutis MA Australia Pty Ltd is notifying of new updates to weight limitations and removal of some weight restrictions for multiple STEMSYS and HACTIV Femoral Stems.
The manufacturer updated the label of those devices as a precautionary measure, and not because of a safety problem with the implants.
Hazard could occur when at least 2 of the conditions of error of dimensioning, orientation and implantation are combined during the installation of the implant. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
-Customers are to be aware of the new labelling changes.
-For patients whose weight exceeds the new limit, Evolutis recommends surgeons to carry out increased monitoring, and encourage patients to maintain an appropriate physical activity. |
| Contact Information |
0488 240471 - jennyburke@neosurgical.com.au - Jenny Burke |