| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00416-1 |
| Product Name/Description |
MUTARS RS Stem and MUTARS RS Extension Sleeve
Item codes: 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515
Multiple Product descriptions
ARTG's 237292, 236019, 236460 and a product supplied via SAS |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Changes have been made to the Instructions for Use (IFU) and Surgical Technique (ST). As part of the certification of the MUTARS RS revision system in accordance with the new European regulation MDR (EU) 2017/745, additional finite element analyses simulating the fatigue tests according to ISO 7206-4 & -6 were carried out. The results of the simulation have prompted the manufacturer to impose additional weight and combination restrictions on the use of some products and sizes. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to read the updated IFU and Surgical Technique provided with the customer letter.
There is no increased risk for patients with previously implanted devices. There is no need for separate aftercare. Healthcare professionals should continue routine follow up care. |
| Contact Information |
1800 060 168 - Life HealthCare |