Safety Information

Medsafe Online Recall Database

Type of Product:	Device
Medsafe Reference:	19300
Brand Name:	JRI VAIOS Shoulder Replacement System
Model:	All models
Affected:	All serial numbers
Software version:
Recalling Organisation:	Orthotech Orthopaedics Limited 11A Alma Street Newmarket Auckland 1149
Contact Information:
Manufacturer:	Joint Replacement Instrumentation Ltd
Issue:	The TGA has cancelled the VAIOS Total Shoulder Replacement System, sponsored by Orthotech, from the Australian Register of Therapeutic Goods (ARTG) due to a higher than expected revision rate. Information published by the Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) indicated that the VAIOS Total Shoulder Replacement System had a revision rate at two years of 17.6%. The comparable revision rate for all other total conventional shoulder implants was 5.5% at two years. The main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis.
Recall action type:	Alert
Recall action:
Level of recall:
Date Commenced:	3/12/2015