| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00578-1 |
| Product Name/Description |
SMR Glenosphere Impactor
Product Code: 9013.74.141
Lot Numbers: 1390763, 14AA094, 14AA528, 15AA557
ARTG Number: 176877 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Lima Orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors.
The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.
If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. Although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to inspect stocks and quarantine the affected units prior to their return.
This action has been closed out on 20/01/2017. |
| Contact Information |
03 9550 0221 - Lima Orthopaedics |