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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00552-1
Product Name/Description	Glenosphere Orientation Guide Instrument used with the Delta EXTEND Reverse Shoulder System. Part number: 230795000 Lot number: 5120443 ARTG number: 137566
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/05/2013
Responsible Entity	Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue	Johnson and Johnson has identified that the arrow used for eccentric Glenosphere orientation is etched on the wrong side of the Glenosphere Guide instrument. Using the wrong side of the guide instrument could result in the misalignment of the eccentric glenosphere with the superior and proximal portion of the shoulder blade.
Recall Action	Hazard Alert
Recall Action Instructions	Surgeons are being advised of the clinical implications of incorrect implant orientation, including the potential for revision surgery. JJM does not recommend the prophylactic revision in the absence of symptoms. For more details, please see http://www.tga.gov.au/safety/alerts-device-glenosphere-orientation-guide-130607.htm .
Contact Information	02 9815 4000 - Johnson and Johnson Medical