| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00804-3 |
| Product Name/Description |
SMR L2 Metal Back Glenoid Component (part of the total shoulder glenoid replacement)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Monitoring and analysis of the clinical results of the SMR L2 Metal Back Glenoid Component indicate that under certain conditions, for example rotator cuff failure or patient trauma, the polyethylene insert can disassociate. The total revision rate of the L2 version of the SMR Metal Back Glenoid Component in Australia is 6.78% at three years. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Lima is contacting all implanting/treating surgeons and advising them on how to manage patients implanted with the L2 component. For more details, please see http://www.tga.gov.au/safety/alerts-device-shoulder-smr-121030.htm . |
| Contact Information |
03 9550 0222 - Lima Regulatory Affairs |