Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13325 |
| Brand Name: | Lima SMR System glenoid components |
| Model: | all models |
| Affected: | all batch numbers |
| Software version: | |
| Recalling Organisation: | Enovis Surgical NZ Ltd 46 Hillside Road Wairau Valley AUCKLAND 0627 |
| Contact Information: | 09 3606010 |
| Manufacturer: | Limacorporate SpA |
| 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 Componet in Australia is 6.78% at three years. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 23/8/2012 |
