Print version of this report
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 Lima Orthopaedics Australia Pty Ltd
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 .
Contact Information 03 9550 0222 - Lima Regulatory Affairs